defibri lad or

8/17/2019 Defibri Lad Or

http://slidepdf.com/reader/full/defibri-lad-or 1/302

DefibrillatorTEC-5521/TEC-5531

0614-008784OPrinted:

First Edition: 18 Aug 2004

Sixteenth Edition: 23 Apr 2015

OPERATOR’S MANUALD efi b r i l l a t or

T E C - 5 5 2 1 / 5 5 3 1

TEC-5500 series

TEC-5521B

TEC-5521E

TEC-5521K

TEC-5531B

TEC-5531E

TEC-5531K

2015/04/03



0614-008784O

If you have any comments or suggestions

on this manual, please contact us at:

www.nihonkohden.com

Defibrillator

TEC-5521/TEC-5531

TEC-5500 series

TEC-5521B

TEC-5521E

TEC-5521K

TEC-5531B

TEC-5531E

TEC-5531K



In order to use this product safely and fully understand all its functions, make sure to read this manual before using the

product.

Keep this manual near the instrument or in the reach of the operator and refer to it whenever the operation is unclear.

This product stores personal patient information. Manage and operate the information appropriately.

Patient names on the screen shots and recording examples in this manual are fctional and any resemblance to any

person living or dead is purely coincidental.

The contents of this manual are subject to change without notice.

Copyright Notice

The entire contents of this manual are copyrighted by Nihon Kohden. All rights are reserved. No part of this document

may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded,or otherwise) without the prior written permission of Nihon Kohden.

Trademark

The mark printed on the SD card that is used in this instrument is a trademark. The company name and model name are

trademarks and registered trademarks of each company.



Operator’s Manual TEC-5500 C.1

1

2

3

4

4-1

4-2

4-3

4-4

5

6

6-1

6-2

6-3

6-4

7

8

9

10

11

ContentsGENERAL HANDLING PRECAUTIONS ............................................................................. i

WARRANTY POLICY ......................................................................................................... ii

EMC RELATED CAUTION ..................................................................................................iii

Conventions Used in this Manual and Instrument .............................................................. v

Warnings, Cautions and Notes ................................................................................. v

Explanations of the Symbols in this Manual and Instrument ................................... vi

Section 1 General ...................................................................................1.1Introduction ......................................................................................................................1.2

Models and Functions ...........................................................................................1.2

Features ................................................................................................................. 1.3

Composition .....................................................................................................................1.4

Caution Labels and Caution Marks .................................................................................. 1.5

Panel Description ............................................................................................................. 1.6

Front Panel ............................................................................................................1.6

Top Panel (TEC-5531 Only) ................................................................................... 1.7

External Paddles....................................................................................................1.8

Left Side Panel ......................................................................................................1.8

Rear Panel .............................................................................................................1.9

ND-590V Series Internal Paddles (Option) ............................................................ 1.9

Important Safety Information .........................................................................................1.10

General ................................................................................................................1.10

Radiofrequency or Electromagnetic Field .................................................1.10

MRI Examination .......................................................................................1.10

Using with ESU .........................................................................................1.11

Surrounding Conditions .............................................................................1.11

Installation ...........................................................................................................1.12

Battery Pack ........................................................................................................1.13

Disposable Pads ..................................................................................................1.14

Defibrillation, Cardioversion and AED .................................................................1.15

General ...................................................................................................... 1.15

With External Paddles ...............................................................................1.17With Disposable Pads ...............................................................................1.18

With Internal Paddles ................................................................................1.18

AED ...........................................................................................................1.19

Pacing .................................................................................................................. 1.20

ECG Monitoring ...................................................................................................1.21

SpO2 Monitoring ..................................................................................................1.22

CO2 Monitoring ....................................................................................................1.24

CO2 Sensor Kit and Airway Adapter ....................................................................1.25

Alarms .................................................................................................................1.26

Maintenance ........................................................................................................1.27Storage ................................................................................................................1.27

Recording Sound ...........................................................................................................1.28



C.2 Operator’s Manual TEC-5500

CONTENTS

Section 2 Preparation ............................................................................2.1Location ........................................................................................................................... 2.2

Surrounding Conditions ......................................................................................... 2.2

Radiofrequency or Electromagnetic Field .............................................................. 2.2

Power ............................................................................................................................... 2.3

AC Operation ......................................................................................................... 2.3

Battery Operation .................................................................................................. 2.3

Using AC Power ............................................................................................................... 2.4

Connecting the Power Cord ................................................................................... 2.4

Cutting Off the Power Supply to the Defibrillator ................................................... 2.4

Using the Battery ............................................................................................................. 2.5

Safety Information about Battery Pack .................................................................. 2.5

Checking the Battery Pack .......................................................................... 2.7

Storage ........................................................................................................ 2.7

Disposal ....................................................................................................... 2.7

Inserting the Battery into the Defibrillator .............................................................. 2.8

Charging the Battery Pack ..................................................................................... 2.9

Trickle Charging ................................................................................................... 2.10

Remaining Battery Power Display .......................................................................2.11

Loading the Recording Paper ........................................................................................2.12

Basic Checks .................................................................................................................2.13

Displaying the Basic Checks Screen ...................................................................2.13

Check Procedure .................................................................................................2.13

Check Before Use ..........................................................................................................2.16

Before Turning On the Power ............................................................................... 2.16

Check Items After Turning the Power On ............................................................. 2.17

Section 3 System Setup Screen and Setup Screen ............................3.1System Setup Screen ...................................................................................................... 3.3

Changing the Items on the System Setup Screen ................................................. 3.3

Configuration ......................................................................................................... 3.4

Setting List ................................................................................................... 3.5

Setting Description ...................................................................................... 3.7

Battery Test ..........................................................................................................3.12

HV Capacitor Test ................................................................................................3.12Recorder Test ......................................................................................................3.12

System Information ..............................................................................................3.13

Report History .....................................................................................................3.13

Use Voice File ......................................................................................................3.13

Setup Screen .................................................................................................................3.15

Setup Item List .....................................................................................................3.15

Changing the Settings on the Setup Screen .......................................................3.16

Paddle Setup .......................................................................................................3.16

ECG Setup ..........................................................................................................3.16

SpO2 Setup ..........................................................................................................3.16CO2 Setup ............................................................................................................3.16

Report Setup .......................................................................................................3.17

Recorder Setup ...................................................................................................3.17




CONTENTS

1

2

3

4

4-1

4-2

4-3

4-4

5

6

6-1

6-2

6-3

6-4

7

8

9

10

11

Date/Screen ......................................................................................................... 3.17

Date and Time ...........................................................................................3.17

2nd Wave ................................................................................................... 3.18

QRS Setup ..........................................................................................................3.18

Alarm Setup .........................................................................................................3.18

Save Report .........................................................................................................3.19

Section 4 Defibrillation, Synchronized Cardioversion and AED ........4.1Section 4-1 General ................................................................................................ 4-1.1

About Defibrillation, Synchronized Cardioversion and AED .........................................4-1.2

Skin-Paddle Contact Impedance ..................................................................................4-1.3

Using the Pediatric Electrode Plate ..............................................................................4-1.4

Changing Paddle Settings ............................................................................................4-1.5

Turning Synchronized Cardioversion with PADDLE Lead On or Off ...................4-1.5

Turning Heart Rate Alarm with PADDLE Lead On or Off ....................................4-1.6Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for

Synchronized Cardioversion .........................................................................................4-1.7

ECG Input from Another Monitor ........................................................................4-1.7

ECG Input from External Paddles, Internal Paddles and Disposable Pads ........4-1.9

Section 4-2 Defibrillation ........................................................................................ 4-2.1

Defibrillation Screen ......................................................................................................4-2.2

Defibrillation with External Paddles ..............................................................................4-2.3

Important Safety Information ..............................................................................4-2.3

Procedure ...........................................................................................................4-2.4Defibrillation with Disposable Pads ............................................................................... 4-2.9


Procedure .........................................................................................................4-2.11

Defibrillation with Internal Paddles ..............................................................................4-2.16

Important Safety Information ............................................................................4-2.16

Procedure .........................................................................................................4-2.17

Section 4-3 Synchronized Cardioversion ............................................................. 4-3.1

Synchronized Cardioversion Screen ............................................................................. 4-3.2

Synchronized Cardioversion with External Paddles......................................................4-3.3


Procedure ...........................................................................................................4-3.4

Synchronized Cardioversion with Disposable Pads ....................................................4-3.10


Procedure .........................................................................................................4-3.12

Synchronized Cardioversion with Internal Paddles .....................................................4-3.18


Procedure .........................................................................................................4-3.19

Section 4-4 AED ...................................................................................................... 4-4.1

AED Screen ..................................................................................................................4-4.2

Important Safety Information ........................................................................................4-4.3




CONTENTS

AED Flowchart ..............................................................................................................4-4.5

Preparation for AED Mode .................................................................................. 4-4.6

AED Procedure .............................................................................................................4-4.7

When Nonshockable Rhythm is Detected in AED Analysis ..............................4-4.15

Section 5 Pacing (TEC-5531 Only) ........................................................5.1About Pacing .................................................................................................................... 5.2

Important Safety Information ........................................................................................... 5.3

Pacing in FIXED Mode ..................................................................................................... 5.4

Information on the Pacing Screen in FIXED Mode ................................................ 5.4

Procedure .............................................................................................................. 5.4

Pacing in DEMAND Mode ..............................................................................................5.11

Information on the Pacing Screen in DEMAND Mode .........................................5.11

Procedure ............................................................................................................5.12

Section 6 Monitoring .............................................................................6.1Section 6-1 General ................................................................................................ 6-1.1

General .........................................................................................................................6-1.2

Displaying the Monitoring Screen .......................................................................6-1.2

Screen Examples ...............................................................................................6-1.2

Section 6-2 ECG Monitoring .................................................................................. 6-2.1

Preparing for ECG Monitoring ......................................................................................6-2.3

Preparation Flowchart ........................................................................................6-2.3

Selecting a Lead .................................................................................................6-2.3

Number of Electrodes and Measuring Leads .....................................................6-2.4

Electrode Position ...............................................................................................6-2.4

3 Electrode Leads ....................................................................................6-2.4

5 Electrode Leads ....................................................................................6-2.5

Selecting Electrodes and Lead ...........................................................................6-2.6

Types of Electrodes and Lead ..................................................................6-2.6

Connecting the ECG Connection Cable or the JC-762V/JC-763V Connection

Cable to the Defibrillator .....................................................................................6-2.7

Connecting the ECG Connection Cable to the Defibrillator ......................6-2.7

Connecting the JC-762V/JC-763V Connection Cable to the

Defibrillator ...............................................................................................6-2.7

Attaching Disposable ECG Electrodes to the Patient .........................................6-2.7

Monitoring ECG with Disposable Pads ...............................................................6-2.8

Monitoring ECG ..........................................................................................................6-2.10

ECG Information on the Monitoring Screen ......................................................6-2.10

Selecting an ECG Lead ..............................................................................................6-2.11

Selecting ECG Sensitivity ...........................................................................................6-2.12

Automatically Adjusting ECG Sensitivity ................................................6-2.12

Changing ECG Settings ..............................................................................................6-2.13

Changing Settings on the ECG Setup Screen ..................................................6-2.13

Turning the AC Hum Filter On or Off ......................................................6-2.14

Changing the Time Constant Setting ......................................................6-2.15




CONTENTS

1

2

3

4

4-1

4-2

4-3

4-4

5

6

6-1

6-2

6-3

6-4

7

8

9

10

11

Turning Pacing Pulse Rejection On or Off ..............................................6-2.16

Changing Heart Rate Upper or Lower Limit ...........................................6-2.17

Changing Settings on the QRS Setup Screen ..................................................6-2.18

Changing QRS Sync Sound Volume ......................................................6-2.19

Changing QRS Sync Sound Source ......................................................6-2.19

Turning the VF/VT Alarm On or Off ........................................................6-2.20

Use with an Electrosurgical Unit .................................................................................6-2.21

Section 6-3 SpO 2 Monitoring .................................................................................. 6-3.1

General .........................................................................................................................6-3.2

Preparing for SpO2 Monitoring ......................................................................................6-3.5


Selecting a Probe ...............................................................................................6-3.5

Reusable Probes ...................................................................................... 6-3.5

Disposable Probes ...................................................................................6-3.6

Connecting Probe to Defibrillator ........................................................................ 6-3.7

Attaching the Probe to the Patient ......................................................................6-3.7

Monitoring SpO2 ...........................................................................................................6-3.9

SpO2 Information on the Monitoring Screen .......................................................6-3.9

Changing SpO2 Settings ............................................................................................6-3.10

Changing Settings on the SpO2 Setup Screen .................................................6-3.10

Changing the Pulse Waveform Sensitivity ..............................................6-3.11

Selecting Sync Sound Pitch ...................................................................6-3.12

Changing the Pulse Rate Alarm Limits ...................................................6-3.13

Changing the SpO2 Alarm Limits ............................................................6-3.14

Changing QRS Sync Sound Volume ................................................................6-3.14

Changing QRS Sync Sound Source .................................................................6-3.14

Section 6-4 CO 2 Monitoring .................................................................................... 6-4.1

General .........................................................................................................................6-4.2

CO2 Sensor Kit ...................................................................................................6-4.3

Preparing for CO2 Monitoring ........................................................................................6-4.5


Connecting the CO2 Sensor Kit to the Defibrillator .............................................6-4.5

Monitoring CO2 ............................................................................................................6-4.6

CO2 Information on the Monitoring Screen .........................................................6-4.6Changing CO2 Settings .................................................................................................6-4.7

Changing Settings on the CO2 Setup Screen .....................................................6-4.7

Changing the CO2 Scale ..........................................................................6-4.8

Changing the ETCO2 Alarm Limits ...........................................................6-4.9

Changing the Respiration Rate Alarm Limits .........................................6-4.10

Changing the APNEA Alarm Limit ..........................................................6-4.11

Inspection of Measuring Accuracy ..............................................................................6-4.12

Daily Inspection of Measuring Accuracy ...........................................................6-4.12

Inspection of Measuring Accuracy (Precise Method) .......................................6-4.12

Checking Procedure ...............................................................................6-4.13




CONTENTS

Section 7 Alarm Function ......................................................................7.1General ............................................................................................................................ 7.2

Alarm Types ........................................................................................................... 7.2

Alarm Indication ..................................................................................................... 7.2

Alarm List............................................................................................................... 7.3

Alarm Status Marks and Messages ...................................................................... 7.4

Temporarily Silencing an Alarm After It Occurs ............................................................... 7.5

Silencing Alarms .................................................................................................... 7.5

Resuming Alarms .................................................................................................. 7.5

Suspending an Alarm Before It Occurs ........................................................................... 7.6

Suspending Alarms ............................................................................................... 7.6

Automatic Alarm Recording ............................................................................................. 7.6

Setting Alarms ................................................................................................................. 7.7

Alarm Setting Range ............................................................................................. 7.7

Setting Alarm Settings on the Alarm Setup Screen ............................................... 7.8

Setting Alarm Settings on the Alarm Setup Screen of the Setup Screen .............. 7.9

Setting Alarms Individually ..................................................................................7.10

Section 8 Recording ..............................................................................8.1About Recording .............................................................................................................. 8.2

Changing Report and Recorder Settings ......................................................................... 8.4

Manual Recording ............................................................................................................ 8.5

Real Time or Delayed Waveform Recording .......................................................... 8.5

Procedure .................................................................................................... 8.5

Report Recording .................................................................................................. 8.6Periodic List Report Recording .................................................................... 8.6

Alarm Report Recording .............................................................................. 8.6

Event List Report Recording .......................................................................8.7

Defibrillation Report Recording ................................................................... 8.9

VF Analysis Report Recording ..................................................................8.10

Trend Report Recording ............................................................................8.11

Event Recording ..................................................................................................8.12

Saving the Administered Medication ...................................................................8.13

Automatic Recording ......................................................................................................8.14

Charging Recording (Auto Recording when Charging Starts After Discharge) ...8.14Alarm Recording ..................................................................................................8.15

Periodic Recording ..............................................................................................8.16

Printed Letters and Marks..............................................................................................8.17

Section 9 Messages and Troubleshooting ...........................................9.1Messages ........................................................................................................................ 9.3

Troubleshooting................................................................................................................ 9.9

General .................................................................................................................. 9.9

Defibrillation .........................................................................................................9.10

Pacing (TEC-5531 Only) ...................................................................................... 9.10

Monitoring ............................................................................................................9.11

ECG ...........................................................................................................9.11




CONTENTS

1

2

3

4

4-1

4-2

4-3

4-4

5

6

6-1

6-2

6-3

6-4

7

8

9

10

11

SpO2 .........................................................................................................9.12

CO2 ...........................................................................................................9.13

Recording ............................................................................................................9.14

Battery .................................................................................................................9.14

SD Card ...............................................................................................................9.15

Section 10 Maintenance ........................................................................10.1Cleaning, Disinfecting and Sterilization..........................................................................10.2

Defibrillator ..........................................................................................................10.2

External Paddles..................................................................................................10.2

Paddle Holders ....................................................................................................10.3

Internal Paddles ...................................................................................................10.3

Battery .................................................................................................................10.4

ECG Electrode Leads, ECG Connection Cable and Pad Adapter ....................... 10.4

Disposal and Replacement ............................................................................................10.5

Battery .................................................................................................................10.5

Disposal of Battery Pack ...........................................................................10.5

Replacing Battery Pack .............................................................................10.5

Disposable Pads ..................................................................................................10.7

Lifetime ......................................................................................................10.7

Disposal ..................................................................................................... 10.7

Test Electrode Plates (On the Paddle Holders) ...................................................10.7

Lifetime ......................................................................................................10.7

ECG .....................................................................................................................10.7

Electrode Lifetime ......................................................................................10.7

Disposing of Electrodes ............................................................................. 10.7

SpO2 and CO2 .....................................................................................................10.7

Check After Use .............................................................................................................10.8

Periodic Inspection ......................................................................................................... 10.9

Daily Inspection ...................................................................................................10.9

Monthly Inspection ...............................................................................................10.9

Checking External Paddles .......................................................................10.9

Checking 270 J Energy Charge and Disarm ...........................................10.10

Battery Test .............................................................................................. 10.11

Checking the Battery Appearance ........................................................... 10.13HV Capacitor Test .................................................................................... 10.14

Recorder Test .......................................................................................... 10.15

Date and Time Adjustment ...................................................................... 10.15

Yearly Inspection................................................................................................ 10.15

Periodical Replacement Schedule ............................................................................... 10.16

Repair Parts Availability Policy ..................................................................................... 10.16

Storage ........................................................................................................................ 10.16

Defibrillator and Battery ..................................................................................... 10.16

Short Term Storage (Ready for Use at Any Time) ................................... 10.16

Long Term Storage .................................................................................. 10.17Disposable Pads and ECG Electrodes .............................................................. 10.17




CONTENTS

Section 11 Reference .............................................................................11.1Specifications ................................................................................................................. 11.2

Defibrillator ..........................................................................................................11.2

Noninvasive Pacing (TEC-5531 Only) .................................................................11.4

External Paddle (ND-552VB/VE/VK) ...................................................................11.4

Battery .................................................................................................................11.4

Clock Accuracy ....................................................................................................11.4

Environment.........................................................................................................11.4

Safety...................................................................................................................11.4

Monitor ................................................................................................................. 11.5

ECG Amplifier ......................................................................................................11.5

Recorder ..............................................................................................................11.5

Rhythm Recognition Detector .............................................................................. 11.5

Power Requirements ...........................................................................................11.6

Dimensions and Weight ....................................................................................... 11.6

Electromagnetic Compatibility .............................................................................11.6

Electromagnetic Emissions .................................................................................11.7

Electromagnetic Immunity ...................................................................................11.7

Recommended Separation Distances between Portable and Mobile RF

Communications Equipment .............................................................................. 11.10

Reference ....................................................................................................................11.11

Standard Accessories ..................................................................................................11.12

Options/Consumables..................................................................................................11.12

Pin Assignment ............................................................................................................11.15

AUX Connector of the QI-553V DSI/AUX OUT Interface Unit ...........................11.15

General Requirements for Connecting Medical Electrical Systems ............................. 11.16



Operator’s Manual TEC-5500 i

GENERAL HANDLING PRECAUTIONS

This device is intended for use only by qualified medical personnel.

Use only Nihon Kohden approved products with this device. Use of non-approved products

or in a non-approved manner may affect the performance specifications of the device. This

includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode

leads, input boxes and AC power.

Please read these precautions thoroughly before attempting to operate the instrument.

1. To safely and effectively use the instrument, its operation must be fully understood.

2. When installing or storing the instrument, take the following precautions.

(1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly

ventilated areas, and dust, saline or sulphuric air.

(2) Place the instrument on an even, level oor. Avoid vibration and mechanical shock, even during transport.

(3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage.

(4) The power line source to be applied to the instrument must correspond in frequency and voltage to product

specications, and have sufcient current capacity.

(5) Choose a room where a proper grounding facility is available.

3. Before Operation

(1) Check that the instrument is in perfect operating order.

(2) Check that the instrument is grounded properly.

(3) Check that all cords are connected properly.

(4) Pay extra attention when the instrument is combined with other instruments to avoid misdiagnosis or other

problems.

(5) All circuitry used for direct patient connection must be doubly checked.

(6) Check that battery level is acceptable and battery condition is good when using battery-operated models.

4. During Operation

(1) Both the instrument and the patient must receive continual, careful attention.

(2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety.

(3) Avoid direct contact between the instrument housing and the patient.

5. To Shutdown After Use

(1) Turn power off with all controls returned to their original positions.

(2) Remove the cords gently; do not use force to remove them.

(3) Clean the instrument together with all accessories for their next use.

6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is

not functioning properly, it should be clearly marked to avoid operation while it is out of order.

7. The instrument must not be altered or modifed in any way.

8. Maintenance and Inspection(1) The instrument and specied parts must undergo regular maintenance inspection at the interval which is specied

after the GENERAL HANDLING PRECAUTIONS section.



Operator’s Manual TEC-5500 iii

EMC RELATED CAUTION

This equipment and/or system complies with International Standard IEC 60601-1-2 for electromagnetic

compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that

exceeds the limits or levels stipulated in IEC 60601-1-2, can cause harmful interference to the equipment

and/or system or cause the equipment and/or system to fail to perform its intended function or degrade

its intended performance. Therefore, during the operation of the equipment and/or system, if there is anyundesired deviation from its intended operational performance, you must avoid, identify and resolve the

adverse electromagnetic effect before continuing to use the equipment and/or system.

The following describes some common interference sources and remedial actions:

1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station

or cellular phone:

Install the equipment and/or system at another location. Keep the emitter source such as cellular phone

away from the equipment and/or system, or turn off the cellular phone.

2. Radio-frequency interference from other equipment through the AC power supply of the equipment and/

or system:

Identify the cause of this interference and if possible remove this interference source. If this is not

possible, use a different power supply.

3. Effect of direct or indirect electrostatic discharge:

Make sure all users and patients in contact with the equipment and/or system are free from direct or

indirect electrostatic energy before using it. A humid room can help lessen this problem.

4. Electromagnetic interference with any radio wave receiver such as radio or television:

If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or

system as far as possible from the radio wave receiver.

5. Interference of lightning:

When lightning occurs near the location where the equipment and/or system is installed, it may induce

an excessive voltage in the equipment and/or system. In such a case, disconnect the AC power cord

from the equipment and/or system and operate the equipment and/or system by battery power, or use

an uninterruptible power supply.

6. Use with other equipment:

When the equipment and/or system is adjacent to or stacked with other equipment, the equipment

and/or system may affect the other equipment. Before use, check that the equipment and/or system

operates normally with the other equipment.

7. Use of unspecified accessory, transducer and/or cable:

When an unspecified accessory, transducer and/or cable is connected to this equipment and/or system,

it may cause increased electromagnetic emission or decreased electromagnetic immunity. The specified

configuration of this equipment and/or system complies with the electromagnetic requirements with the

specified configuration. Only use this equipment and/or system with the specified configuration.



iv Operator’s Manual TEC-5500

Caution - continued

8. Use of unspecified configuration:

When the equipment and/or system is used with the unspecified system configuration different than

the configuration of EMC testing, it may cause increased electromagnetic emission or decreased

electromagnetic immunity. Only use this equipment and/or system with the specified configuration.

9. Measurement with excessive sensitivity:

The equipment and/or system is designed to measure bioelectrical signals with a specified sensitivity. If

the equipment and/or system is used with excessive sensitivity, artifact may appear by electromagnetic

interference and this may cause mis-diagnosis. When unexpected artifact appears, inspect the

surrounding electromagnetic conditions and remove this artifact source.

If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden

representative for additional suggestions.

For EMC compliance, refer to “Specications - Electromagnetic Compatibility” in the Reference section.

The CE mark is a protected conformity mark of the European Community. Products with the CE mark comply

with the requirements of the Medical Device Directive 93/42/EEC.

NOTE about Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC

For the member states of the European Union only:

The purpose of WEEE directive 2002/96/EC is, as a first priority, the prevention of waste electrical and

electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of suchwastes so as to reduce the disposal of waste.

Contact your Nihon Kohden representative for disposal.



Operator’s Manual TEC-5500 v

Conventions Used in this Manual and Instrument

Warnings, Cautions and NotesWarnings, cautions and notes are used in this manual to alert or signal the reader to specic information.

WARNINGA warning alerts the user to possible injury or death associated with the use or misuse of the instrument.

CAUTION

A caution alerts the user to possible injury or problems with the instrument associated with its use or

misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other

property.

NOTE

A note provides specific information, in the form of recommendations, prerequirements, alternative methods orsupplemental information.



vi Operator’s Manual TEC-5500

Explanations of the Symbols in this Manual and Instrument

The following symbols found in this manual/instrument bear the respective descriptions as given.

On the Main Unit

Symbol Description Symbol Description

AC power operation Output terminal

Charging Input terminal

Charged (Battery charging is nished) Dangerous voltage

ECG lead ECG

ECG sensitivity Pacing start

Alarm off Pacing stop

Real time delayed recording Attention, consult operator’s manual

Event recording Provides ActiBiphasic waveform

debrillation function

Inserting or removing the memory card IPX1 Complies with IEC 60529 IPX1

Debrillation-proof type BF applied

part IPX4 Complies with IEC 60529 IPX4

Debrillation-proof type CF applied

part IPX7 Complies with IEC 60529 IPX7

The CE mark is a protected conformity

mark of the European Community.

Products marked with this symbol

comply with the requirements of the

Medical Device Directive 93/42/EEC.

Products marked with this symbol

comply with the European WEEE

directive 2002/96/EC and require

separate waste collection. For Nihon

Kohden products marked with this

symbol, contact your Nihon Kohden

representative for disposal.



Operator’s Manual TEC-5500 1.1

1

Section 1 General

Introduction ..........................................................................................................................................................1.2

Models and Functions ...............................................................................................................................1.2

Features ....................................................................................................................................................1.3

Composition.........................................................................................................................................................1.4

Caution Labels and Caution Marks .....................................................................................................................1.5

Panel Description ................................................................................................................................................1.6

Front Panel ................................................................................................................................................1.6

Top Panel (TEC-5531 Only) ......................................................................................................................1.7

External Paddles .......................................................................................................................................1.8

Left Side Panel ..........................................................................................................................................1.8Rear Panel ................................................................................................................................................1.9

ND-590V Series Internal Paddles (Option) ...............................................................................................1.9

Important Safety Information .............................................................................................................................1.10

General....................................................................................................................................................1.10

Radiofrequency or Electromagnetic Field .....................................................................................1.10

MRI Examination ...........................................................................................................................1.10

Using with ESU .............................................................................................................................1.11

Surrounding Conditions ................................................................................................................. 1.11

Installation ...............................................................................................................................................1.12

Battery Pack ............................................................................................................................................1.13Disposable Pads......................................................................................................................................1.14

Defibrillation, Cardioversion and AED .....................................................................................................1.15

General .........................................................................................................................................1.15

With External Paddles ...................................................................................................................1.17

With Disposable Pads ...................................................................................................................1.18

With Internal Paddles ....................................................................................................................1.18

AED ...............................................................................................................................................1.19

Pacing .....................................................................................................................................................1.20

ECG Monitoring .......................................................................................................................................1.21

SpO2 Monitoring ......................................................................................................................................1.22

CO2 Monitoring ........................................................................................................................................1.24

CO2 Sensor Kit and Airway Adapter ........................................................................................................1.25

Alarms .....................................................................................................................................................1.26

Maintenance ............................................................................................................................................1.27

Storage ....................................................................................................................................................1.27

Recording Sound ...............................................................................................................................................1.28



1


1. GENERAL

Features

Biphasic waveform debrillation

The debrillator provides biphasic waveform debrillation. Biphasic waveform

debrillation requires low energy than conventional monophasic debrillation.

Display

The display is 5.7-inch color LCD. ECG waveforms and messages are easy to

see. You can select either 25 or 50 mm/s for sweep speed.

Selectable power sources, AC/Battery

Either AC or battery power can be selected according to where it is used.

Fast charging

Charges from 0 to 270 J within 5 seconds in both AC and battery operation

(with a fully charged new battery at 20°C). Charges from 0 to 200 J within 3

seconds in both AC and battery operation. This enables timely debrillation and

cardioversion.

Quick ECG waveform recovery

After debrillation or cardioversion, the ECG waveform returns within 3 seconds

so you can immediately check the result of debrillation or cardioversion.

AED function

During ECG analysis, if the debrillator detects a shockable rhythm, it

automatically charges energy to prepare for debrillation.

Noninvasive pacing (only for TEC-5531 debrillator)

The TEC-5531 debrillator has noninvasive pacing. This is useful for rst aid for

bradycardia that often appears after debrillation.

SpO2 and CO2 monitoring

With the optional DSI interface unit or DSI/AUX OUT interface unit, SpO2 and

CO2 can be monitored on the debrillator.

Voice prompt

This function is mainly used in AED mode. Debrillator status and cautions

during debrillation are directed by voice.

Basic function check

The debrillator has a semi-automatic self check function for discharge, battery,

recording, alarm sound and voice. You can easily check the debrillator before

use on the debrillator screen.

SD card

ECG waveforms, report data and surrounding sound can be recorded and

transferred to a personal computer with a specied SD card.



1.4 Operator’s Manual TEC-5500

1. GENERAL

Composition

TEC-5500 Series Defibrillator Standard Accessories

Name Qty

Recording paper (Z-fold) 1

Contact gel GELAID 1

Battery check label (for debrillator) 1

Options

Disposable pads P-511 Internal paddles Cart KD-028A, Cart tray assembly DI-001A

O P E R

/ A L A R M

C O 2 A D

A P T E R

SpO2 adapter JL-550T2 CO2 sensor kit TG-901T3 CO2 sensor kit TG-921T3

H O P E R / A L A

R M

C O

2 A D

A P T E

R

JG-921T3 CO2 adapter

TG-121T

CO2 sensor


TG-101T CO2 sensor

Name

TEC accessory set (100 V/IEC)

BC-763V ECG connection cable (IEC, 3 leads) + Power cord H

TEC accessory set (200 V/IEC)

BC-763V ECG connection cable (IEC, 3 leads) + Power cord N

TEC accessory set (100 V/AHA)

BC-763VA ECG connection cable (AHA, 3 leads) + Power cord H

TEC accessory set (200 V/AHA)BC-763VA ECG connection cable (AHA, 3 leads) + Power cord N

QI-552V DSI interface unit

QI-553V DSI/AUXOUT interface unit



1


1. GENERAL

Caution Labels and Caution Marks

This section provides information on caution labels and caution marks on the

instrument.

WARNING

Connect only the specified instrument to the defibrillator and follow

the specified procedure. Failure to follow this warning may result in

electrical shock or injury to the patient and operator, and cause fire

or instrument malfunction.

Refer to Section 4 “Debrillation, Synchronized Cardioversion

and AED”, Section 6-2 “ECG Monitoring” and Section 9“Messages and Troubleshooting”.

Refer to Section 5 “Pacing”.

Left side panel:

Refer to “Using the Battery” and

“Loading the Recording Paper” in

Section 2.

Refer to Section 6-2

“ECG Monitoring”.

Refer to Section 6-3 “SpO2 Monitoring ”

and Section 6-4 “CO2 Monitoring”.

Refer to Section 4 “Debrillation, Synchronized

Cardioversion and AED”.



1


1. GENERAL

12

13

14 15 16 17

18

19

20

No. Name Description

12 Record key Starts recording with the recorder. To stop recording, press this

key again.

13 Event key Starts event recording. When this key is pressed, the recorded

waveforms are saved as an event in the summary recording data.

14 ECG lead key Changes ECG leads.

15 ECG sensitivity key Changes ECG sensitivity.16 Silence alarms key Temporarily suspends or silences alarms.

17 Multi-function key In the monitor mode, opens the alarm setup screen. You can

conrm or change alarm settings. In AED mode, this key changes

to Pause key.

18 AC lamp Lights when AC power is supplied to the debrillator.

19 Battery charging lamp Lights when the battery is being charged.

20 Battery charge complete

lamp

Lights when the battery is completely charged.

Top Panel (TEC-5531 Only)

1 3 6

2 4 5


1 PACING RATE Up key Increases the pacing frequency (pulse/minute).

2 PACING RATE Down key Decreases the pacing frequency (pulse/minute).

3 PACING OUTPUT Up key Increases the pacing current intensity.

4 PACING OUTPUT Down

key

Decreases the pacing current intensity.

5 START/STOP key Press to start or stop pacing.

6 PULSE lamp Blinks in synchronization with the pacing pulse.




1. GENERAL

External Paddles4

1 2 3

4


1 CONTACT lamp Indicates the quality of contact between paddles and patient. The

GOOD (green) lamp must light.

0 to 100 Ω: Green lamp lights

100 to 200 Ω: Yellow lamp lights

More than 200 Ω: Orange lamp lights

2 CHARGE button Press to charge the selected energy.

3 CHARGE lamp Blinks while the selected energy is being charged. Lights when

the energy is completely charged.

4 DISCHARGE buttons Simultaneously press both buttons to discharge the charged

energy. In synchronized cardioversion, the debrillator discharges

energy at the appropriate timing after these buttons are pressed.

Left Side Panel

2

1

4 3


1 Recording paper exit The recorded paper comes from this slit. A cutter to cut the paper

is attached here.

2 Door release lever Pull the lever up to open the door.

3 SD card slot Insert an SD card here. To remove the card, push it in.

4 Battery pack holder Contains the battery.



1


1. GENERAL

Rear Panel1 2


1 AC SOURCE socket Connects the AC power cord to supply AC power.

2 Optional unit connector Optional unit is connected. When not used, attach the cover here.

ND-590V Series Internal Paddles (Option)1

2 3

4


1 Paddle connector Connects to the paddle connector on the debrillator front panel.

2 Paddle electrodes Place these electrodes against the right and left sides of the heart.

3 Handles Grip these handles holding between the cable and the guard of the handle.

4 Discharge switch Discharges the charged energy.




1. GENERAL

Important Safety Information

General

WARNINGNever use the defibrillator in the presence of any

flammable anesthetic gas or high concentration

oxygen atmosphere. Failure to follow this warning

may cause explosion or fire.

ECG monitoring might not be performed properly.

WARNINGNever use the defibrillator in a hyperbaric oxygen

chamber. Failure to follow this warning may cause

explosion or fire.

WARNING

The defibrillator generates high voltage. The

defibrillator must only be operated by trained and

qualified medical personnel.

Radiofrequency or Electromagnetic Field

WARNING

Do not use any kind of non-essential non-patient

care device within a radius of 1 meter around

the defibrillator. The use of non-essential non-

patient care devices that emit radiofrequencyor electromagnetic fields may interfere with the

operation of the defibrillator by causing noise on

the ECG waveform or error messages. If a non-

essential non-patient care device is accidentally

placed near the defibrillator, quickly remove it.

MRI Examination

WARNINGDo not take this defibrillator into the MRI test

room. This defibrillator is not designed to be used

during MRI tests.

WARNINGWhen performing MRI test, remove all electrodes

and transducers from the patient which are

connected to this instrument. Failure to follow this

warning may cause skin burn on the patient. For

details, refer to the MRI manual.



1


1. GENERAL

Using with ESU

WARNING

When the defibrillator is used with an

electrosurgical unit (ESU), firmly attach the entire

area of the ESU return plate. Otherwise, the

current from the ESU flows into the electrodes of

the defibrillator, causing electrical burn where the

electrodes are attached. For details, refer to the

ESU manual.

WARNING

When using an ESU, use this defibrillator

only in the MONITOR mode and use the ECG

electrodes for monitoring. Do not monitor ECG

with disposable pads, external paddles or

internal paddles. If ECG is monitored with pads

or paddles, high frequency energy from the ESU

causes abnormal current to flow in the patient

and unexpected discharge. This may damage the

defibrillator.

Surrounding Conditions

WARNING

Fluids such as Ringer’s saline solution and blood

are excellent electrical conductors; to avoid

creating potentially dangerous electrical paths,

keep the defibrillator and the immediate area

clean and dry at all times.

CAUTION

Turn off the power of mobile phones, small

wireless devices and other devices which

produce strong electromagnetic interference

around a patient (except for devices allowed by

the hospital administrator). Radio waves from

devices such as mobile phones or small wireless

devices may cause the incorrect data to be

displayed.

CAUTION

Install the defibrillator and ESU appropriately

and perform equipotential grounding. Otherwise,

noise from the ESU may be falsely recognized

as QRS and ECG monitoring might not be

performed properly.

CAUTION

Only use Nihon Kohden products and specifiedparts and accessories. When other parts are

used, the defibrillator may overheat and be

damaged and monitoring may stop.

CAUTION

Do not reuse disposable items.




1. GENERAL

Installation

WARNING

Connect only the specified instrument to the

defibrillator and follow the specified procedure.

Failure to follow this warning may result

in electrical shock or injury to the patient

and operator, and cause fire or instrument

malfunction.

WARNING

Only use the provided power cord. Using other

power cords may result in electrical shock or

injury to the patient and operator.

WARNING

Only use the provided power cord. When the

provided power cord cannot be used or when

equipotential grounding is doubtful (such as in

poor grounding facility), operate the defibrillator

on battery power. Otherwise, the patient andoperator may receive electrical shock or injury.

WARNING

When several medical instruments are used

together, ground all instruments to the same one-

point ground. Any potential difference between

instruments may cause electrical shock to the

patient and operator.

WARNING

Do not connect several grounding leads directly

to the equipotential terminal because the

grounding lead may be disconnected from the

terminal.

CAUTIONThe defibrillator should only be connected to

external equipment which complies with the

CISPR 11 Second Edition 1990-09, Group 1 and

Class B standard.

CAUTIONOnly use the KD-028A cart for this defibrillator.

If another cart is used, it may tip over or the

defibrillator may fall off.

CAUTION

Never disassemble or repair the defibrillator.

Disassembly and repair must be performed by

qualified service personnel.



1


1. GENERAL

Battery Pack

WARNING

Do not do the following to the battery. It may

cause leakage, overheating, explosion and fire.

• Short-circuit the + and – terminals on the

battery.

• Put the battery into fire or heat the battery.

• Disassemble or modify the battery.

• Give strong impact to or deform the battery.

• Use the battery on unspecified instruments.

• Charge the battery on unspecified instruments.

• Install the battery with the wrong polarity.

• Leave the battery in the reach of patients.

WARNING

• Test the battery pack once a month.

• When you start using a new battery pack, write

the date of first use on the labels on the battery

pack and defibrillator.

• Replace the battery pack every two years.

• If defibrillation or cardioversion is necessary

during the battery test, cancel the battery test

and operate the defibrillator on AC power. Do

not use battery power because the battery pack

may have been discharged by the battery test.

WARNINGIf the battery pack is damaged and the substance

inside the battery pack contacts the eyes or skin,

wash immediately and thoroughly with water and

see a physician. Never rub your eyes, because

you may lose your eyesight.

WARNING• Do not immerse the battery pack in water.

The battery may overheat and rust and the

substance inside the battery may leak.

• Do not leave the battery pack unused for more

than about one year. The battery may leak.

CAUTION

When inserting or removing the battery pack,

disconnect the power cord from the defibrillator.

Otherwise, the operator may receive electrical

shock.

CAUTION

To keep the battery pack fully charged, always

keep the power cord connected to the AC

outlet even when the defibrillator is not used.

Otherwise, the battery pack may discharge and

become unusable.

CAUTION

Do not expose the battery pack to direct sunlight

or leave in a high temperature place. The

lifetime of the battery pack may be shortened,

the performance of the battery pack may be

degraded and the battery may leak.

CAUTION

The battery pack must be replaced by qualified

service personnel.

CAUTION

Do not leave the battery pack near the patient or

in reach of children.

NOTE

Before disposing of the battery, check with your local

solid waste officials for details in your area for recycling

options or proper disposal. The battery is recyclable. At

the end of its useful life, under various state and local

laws, it may be illegal to dispose of this battery into the

municipal waste stream.




1. GENERAL

Disposable Pads

WARNING

Failure to follow the warnings below may cause

skin burn or insufficient energy discharge and

insufficient pacing current to the heart.

• Do not reuse disposable pads.

• If the pad package is torn, dispose of the pads

and do not use them.

• Do not use the pads if they are past the

expiration date on the package.

• Use the disposable pads as soon as possible

after opening the package.

• Do not use the disposable pads if the gel has

become dry or if the gel has become abnormal

(the gel has become liquid or is coming off the

edges of the pad, etc).

• Do not use the disposable pads if the gel

is dark brown or dark brown gel is on the

protective sheet.

WARNING

If any pad or connector gets wet, replace it with a

new one. If a wet pad or connector is used, it may

cause electrical shock.

WARNING

When using the disposable pads for long term

pacing, replace them every hour. Failure to follow

this warning may cause skin burn or insufficient

energy discharge and pacing current to the heart.

CAUTION


ECG monitoring, replace them every 24 hours.

Failure to follow this instruction may cause

insufficient pacing current and insufficient energydischarge to the heart.

CAUTION

Do not attach a disposable pad over another pad.

It may cause skin burn on the patient.

CAUTION

Do not put heavy objects on the disposable pads

or bend the pads. The pads may be damaged

and deteriorated, resulting in skin burn on the

patient.

CAUTION

When you monitor ECG that is acquired with

the disposable pads, check the polarity of the

pads before attaching them on the patient. If the

pad polarity is incorrect, the waveform appears

upside-down and this may cause incorrect

judgment by the operator and delay of treatment.



1


1. GENERAL

Defibrillation, Cardioversion and AED

General

WARNING

Before defibrillation and cardioversion, check

that the cords and cables of the electrodes,

probes and transducers attached to the patient

are properly connected to a connector that has

a or mark. Touching the metal parts of

the disconnected cords and cables may cause

electrical shock or injury by discharged energy.

WARNING

Before defibrillation and cardioversion, remove

from the patient all electrodes, probes and

transducers from connectors that do not have a

or mark. Otherwise, the operator may

receive electrical shock and the connected

instrument may be damaged.

WARNING

Before defibrillation and cardioversion, remove

everything including electrodes and patches

from the patient’s chest. If the defibrillator paddlecontacts an object on the patient’s chest, the

discharged energy may be insufficient and cause

skin burn.

WARNING

Before defibrillation and cardioversion, all

persons must keep clear of the bed and must

not touch the patient or any equipment or cableconnected to the patient. Failure to follow this

warning may cause electrical shock or injury.

WARNING

Do not move the defibrillator when any charged

energy remains in the defibrillator. If the

defibrillator receives any impact, such as from

falling, it discharges energy that can cause

electrical shock.

WARNING

Use the ECG monitoring electrodes (disposable

electrodes) to monitor the ECG waveforms.

Stable ECG cannot be acquired with the PADDLE

lead because it is difficult to hold the paddles

stable. ECG acquired from external paddles,

internal paddles or disposable pads is unstable

after discharge because of high polarization

voltage.

WARNING

Do not perform defibrillation or cardioversion in a

wet place. Before defibrillation or cardioversion,

move the patient and defibrillator to a dry place.

Otherwise the operator may get electrical shock.

WARNING

Never discharge near a person or object other

than the patient or test electrode plate or energy

checker. It may cause electrical shock to the

person or damage the object.




1. GENERAL

WARNING

Confirm that there is no noise on the ECG. Noise

may be misrecognized as QRS and discharge

might not synchronize with the patient’s QRS.

WARNING

• For this defibrillator, the CONTACT lamp on

the STERNUM paddle indicates skin-paddle

contact impedance. If the yellow or orange

lamp lights, the defibrillator may cause serious

electric burn on the patient s skin and poorenergy discharge to the patient. In case of an

emergency, medical personnel should decide

whether to execute discharge immediately,

regardless of the CONTACT lamp display,

or take action to make good contact before

discharge.

• Pay careful attention to the selected energy

when using the pediatric electrode plates.

Applying high energy with the pediatric

electrode plates can cause skin burn because

the electrode plates are small.

• The apex-posterior placement is not suitable for

ECG monitoring or AED analysis.

• The anterior-posterior placement is not suitable

for ECG monitoring or AED analysis. Use this

placement only for pacing.

• Make sure to push the connector of the

paddles/pads all the way into the paddle

connector until it clicks. Even if the connector is

not firmly connected to the paddles connector,

the “Connect paddle” message might not

appear. If the connector is loose, it may

become disconnected or energy might not be

discharged.

• Pay careful attention to the selected energy

when performing defibrillation on children.

Performing defibrillation with high energy may

cause fatal damage to the heart.

WARNING

Do not perform synchronized cardioversion

with the PADDLE lead unless it is absolutely

necessary. In synchronized cardioversion with the

PADDLE lead, noise may be misrecognized as

QRS and discharge might not synchronize with

the patient’s QRS.

WARNING

Never select “TEST” for the ECG lead. “TEST”

is for maintenance and the waveform displayed

on the screen is not the patient’s ECG. If

synchronized cardioversion is performed with the

TEST lead, the discharge is not synchronized

with the patient’s QRS and it may cause

ventricular fibrillation.

WARNING

If you use the ECG signal from the monitor,before cardioversion, check that the defibrillator

discharge occurs within 60 ms of the peak of the

ECG’s R wave with an energy checker. If this

condition is not met, the cardioversion may be

ineffective or may cause ventricular fibrillation.

CAUTION

When performing synchronized cardioversion,

confirm that the SYNC lamp is lit before every

discharge. If “Sync mode after CV” is set to

Defib on the System Setup - Configuration

screen, the defibrillator automatically turns to the

asynchronous defibrillation mode.

CAUTION

Have another defibrillator ready in case

of defibrillator failure. When using another

defibrillator, remove the paddles of the failed

defibrillator from the patient.



1


1. GENERAL

With External Paddles

WARNING

Apply contact gel only to the electrode plates of

the external paddles. Otherwise, it may cause

electrical shock to the operator.

WARNING

Do not apply contact gel by hand. Failure to follow

this warning may cause serious electrical burn,

shock, or other injury.

WARNING

Do not hold the paddle handles if your hands are

wet or have contact gel on them. This may cause


WARNING

To prevent skin burn on the patient and poor

energy discharge to the heart, apply contact gel

evenly to the electrode plates of the external

paddles.

WARNING

Do not touch the electrode plate or edge of the

paddle. Failure to follow this warning may cause

serious electrical burn, shock, or other injury.

WARNING

When charging or discharging, do not touch

anything other than the handles. If any other part

of the defibrillator is touched during charging or

discharging, the operator receives an electrical

shock.

WARNING

Before discharging, confirm that the paddles are

firmly pressed against the chest wall. Failure

to follow this warning causes skin burn or poor

energy discharge to the heart.

WARNING

Do not discharge with the paddles in the air. This

may cause electrical shock to the operator or

damage the defibrillator.

WARNING

Do not discharge the energy if the paddles are

shorted to each other by contact gel. It may

cause skin burn and poor energy discharge to the

heart.

CAUTION

When using the external paddles, connect it

to the paddle connector until it clicks. After

connecting the external paddles, use the Basic

checks screen to check that the defibrillator

charges and discharges energy properly. If the

energy is not discharged, the connector of the

external paddles might not be firmly connected

to the paddle connector. In this case, push the

connector of the external paddles into the paddle

connector deeply until it clicks.

CAUTION

If the patient’s body is wet, thoroughly wipe the

moisture off the skin so that the paddles do not

short to each other. Otherwise, the discharged

energy may be insufficient.




1. GENERAL

With Disposable Pads

WARNING

• Do not attach pads on the papilla, electrodes or

medicine on the patient’s body. Failure to follow

this warning causes serious skin burn.

• Fit the pad closely to the body surface so that

current flows uniformly through the pad. Failure

to follow this warning causes serious skin burn

or insufficient energy discharge to the heart.

WARNINGDuring charging or discharging, do not touch the

pads or connectors. Failure to follow this warning

causes electrical shock to the operator.

WARNING

Before discharging, confirm that the pads are

firmly attached to the skin. Failure to follow

this warning causes skin burn or poor energy

discharge to the heart.

WARNINGDo not discharge if the pads overlap each

other or are shorted to each other by anything

conductive such as contact gel. This may cause

skin burn and poor energy discharge to the heart.

CAUTION

Do not bend or damage the connector pins of

the pad adapter and paddle connector. Energy

cannot be fully discharged if pins are bent or

damaged.

CAUTION


moisture off the skin so that the pads do not short

to each other. Otherwise, the discharged energy

may be insufficient.

With Internal Paddles

WARNING

Sterilize the internal paddles before use. Failure

to sterilize the paddles may cause serious

infection.

WARNING

Pay careful attention to the selected energy when

using internal paddles. Applying high energy to

the heart may cause cardiac muscle necrosis.

Low energy is recommended.

WARNING

When charging or discharging, grip the internal

paddles between the cable and the guard at

the top of the handle. If the internal paddles are

gripped between the electrode and the guard, the

operator receives an electrical shock.

Guard

WARNING




WARNING

Before discharging, confirm that the paddles

are firmly positioned against the heart. Failure

to follow this warning causes cardiac muscle

necrosis or poor energy discharge to the heart.



1


1. GENERAL

CAUTION

Do not twist the internal paddle while holding the

electrode or give strong impact to the paddle. It

damages the electrode.

CAUTION


the paddle connector. Energy cannot be fully

discharged if pins are bent or damaged.

AED

WARNING

• Do not attach pads on the papilla, electrodes or

medicine on the patient’s body. Failure to follow

this warning causes serious skin burn.


current flows uniformly through the pad. Failure

to follow this warning causes serious skin burn

or insufficient energy discharge to the heart.

WARNING

When you perform defibrillation in an ambulance,

stop the car.

WARNING

During charging or discharging, do not touch the



WARNING





WARNING

Do not discharge if the pads overlap each




CAUTION

Before ECG analysis in AED mode or

defibrillation, confirm that the patient is

unconscious and has no respiration and no pulse.

CAUTION

The ECG of a child or a patient with an implanted

pacemaker cannot be analyzed correctly. For

these patients, follow the physician’s instruction.

CAUTION

Before and during ECG analysis in AED mode,

note the following. Otherwise, correct analysis

result cannot be obtained.

• Do not touch or move the patient.• Stop life saving treatment such as CPR.

• If the ECG baseline wanders due to conditions

such as poor skin-pad impedance or movement

of the pad adapter or pad cable, remove the

causes.

CAUTION


the pad adapter and paddle connector. Energy

cannot be fully discharged if pins are bent or

damaged.

CAUTION

Asystole is not judged to be a shockable rhythm

and the defibrillator does not automaticallycharge the energy.

CAUTION


moisture off the skin so that the pads do not shortto each other. Otherwise, the discharged energy

may be insufficient.




1. GENERAL

Pacing

WARNING

Do not perform pacing while using an ESU.

Before using the ESU, turn the defibrillator power

off and remove disposable pads from the patient.

Otherwise, high frequency energy from the ESU

causes abnormal current to flow into the patient

and causes electrical burn, shock or other injury.

It also damages the defibrillator.

WARNING

Always monitor the ECG waveform with the ECG

connection cable and ECG electrodes.

WARNING


may be misrecognized as QRS and correct

pacing cannot be performed.

WARNING

Do not touch the patient, pads or connectors

during pacing. It may cause electrical shock.

WARNING

The pacing rate must be determined by qualified

medical personnel based on the heart rate of the

patient in a normal state.

WARNING

The pacing current must only be increased by

qualified medical personnel decision.

WARNING

Keep the current intensity as low as possible to

minimize pain and discomfort to the patient.

WARNING

Failure to follow the following warnings causes

serious skin burn.

• Do not attach the pads over ECG electrode.• Do not attach pads on the papilla or medicine

on the patient’s body.


current flows uniformly through the pad. This

reduces the required pacing current and pain

and discomfort to the patient.

WARNING

The apex-posterior placement is not suitable for


WARNING

The anterior-posterior placement is not suitable

for ECG monitoring or AED analysis. Use this


WARNING

Never select “TEST” for the ECG lead. “TEST”

is for maintenance and the waveform displayed

on the screen is not the patient’s ECG. If

synchronized cardioversion is performed with the

TEST lead, the discharge is not synchronized

with the patient’s QRS and it may cause

ventricular fibrillation.

WARNING

Do not change the sensitivity or ECG lead setting

after pacing is started. If sensitivity or lead is

changed, the pacing stops for 3 seconds. Failure

to follow this warning may cause serious heart

attack.



1


1. GENERAL

WARNING

No QRS wave is detected:

• For 240 ms after the pacing pulse is output, if

the pacing rate is set to 100 ppm or more.


the pacing rate is set to 90 ppm or less.

CAUTION

Always check that the pacing pulse is effective by

observing the ECG on the screen during pacing.

CAUTION


the paddle connector. Energy cannot be fully

discharged if pins are bent or damaged.

CAUTION


moisture off the skin so that the paddles do not

short to each other. Otherwise, the discharged


ECG Monitoring

WARNING

When using a defibrillator together with the

monitor, use Ag/AgCl electrodes. Other types

of electrodes, stainless steel in particular, will

adversely affect the ECG waveform by slowing

the baseline recovery on the monitor and result in

no monitoring immediately following defibrillation.

WARNING

Even when the pacing pulse rejection is set to

ON, the pacemaker pulse can be overlooked

or detected as QRS. You cannot confirm the

pacemaker operation only from the detected

pacemaker pulse.

WARNING

• The apex-posterior placement is not suitable for


• The anterior-posterior placement is not suitablefor ECG monitoring or AED analysis. Use this


WARNING

Turn pacing pulse rejection to OFF when

monitoring a child, baby or infant. When pacing

pulse rejection is set to ON, narrow width QRSof a child cannot be detected correctly and the

defibrillator may miscount QRS.

CAUTION

When the “Check ECG Electrodes” message is

displayed, ECG is not monitored properly and

the ECG alarm does not function. Check the

electrode, electrode leads and connection cord,

and if necessary, replace with new ones.

CAUTION

Turn the pacing pulse rejection to On when

monitoring a pacemaker patient. Otherwise QRS

and pacemaker pulse might not be distinguished

and pacing failure might not be recognized.




1. GENERAL

SpO2 Monitoring

WARNING

SpO2 measurement may be incorrect in the

following cases.

• When the patient’s carboxyhemoglobin or

methemoglobin increases abnormally.• When dye is injected in the blood.

• When using an electrosurgical unit.

• During CPR.

• When measuring at a site with venous pulse.

• When there is body movement.

• When the pulse wave is small (insufficient

peripheral circulation).

WARNING

When not monitoring SpO2, disconnect the SpO2

connection cord from the defibrillator. Otherwise,

noise from the probe sensor may interfere and

incorrect data is displayed on the screen.

WARNING

When measuring SpO2 of a patient who is in

a state of shock or in CPR (cardiopulmonary

resuscitation), the acquired SpO2 data may be

incorrect due to the patient’s body movement.

WARNING

When monitoring SpO2 of a patient who is

receiving photodynamic therapy, the light from

the finger probe sensor may cause a burn.

Photodynamic therapy uses a photosensitizing

agent that has a side effect of photosensitivity.

The SpO2 probe manufactured by Nihon Kohden have two

wavelengths with peaks in the range of 650 and 950 nm. The

maximum light intensity is less than 5.5 mW.

WARNING

Check the circulation condition by observing the

skin color at the measurement site and pulse

waveform. Change the measurement site every

8 hours for disposable probes and every 4 hours

for reusable probes (every 8 hours for TL-631T3

probe). The skin temperature may increase at the

attached site by 2 or 3°C (4 or 5°F) and cause a

burn or pressure necrosis. When using the probe

on the following patients, take extreme care and

change the measurement site more frequently

according to symptoms and degree.

• Patient with a fever

• Patient with insufficient peripheral circulation

• Neonate or low birth weight infant with delicate

skin

WARNING

• When using the TL-201T finger probe, do

not fasten the probe and cable to the finger

by wrapping with tape. This may cause burn,

congestion or pressure necrosis from poor

blood circulation.

• When using probes other than the TL-201T

finger probe, to avoid poor circulation, do

not wrap the tape too tight. Check the blood

circulation condition by observing the skin

color and congestion at the skin peripheral to

the probe attachment site. Even for short-term

monitoring, there may be burn or pressure

necrosis from poor blood circulation, especially

on neonates or low birth weight infants whoseskin is delicate. Accurate measurement cannot

be performed on a site with poor peripheral

circulation.



1


1. GENERAL

CAUTION

Handle the probe cable according to the following

cautions. Failure to follow these cautions may

cause cable discontinuity or short circuit of

the probe cable which may cause incorrect

measurement data or inability to performmeasurement. Also in rare cases, the probe

temperature may increase and cause skin burn

on the patient. If the probe cable is damaged,

replace the probe with a new one.

• Do not pull or bend the probe cable.

• Do not let caster feet run over the probe cable.

CAUTION

Do not immerse the disposable probe in

detergent or water. If the probe adhesive surface

gets wet, the adhesiveness becomes weak and

the probe cannot be attached to the skin. Also,

it may cause incorrect data and skin burn on thepatient.

CAUTION

Only use the specified probes. Otherwise SpO2

cannot be monitored properly and instrument

performance may be degraded.

CAUTION





the hospital administrator). Radio waves from

devices such as mobile phones or small wireless

devices may be mistaken as pulse waves and the

displayed data may be incorrect.

CAUTION

Do not use a probe which is deteriorated

by aging. Accurate measurement cannot be

performed.

CAUTIONDo not use a damaged or disassembled probe.

It causes incorrect measurement and may injure

the patient.

CAUTIONThe disposable probe is not sterilized. Use the

disposable probe only for a single patient. Never

reuse the disposable probe for another patient

because it causes cross infection.

CAUTION

If the attachment site is dirty with blood or bodily

fluids, clean the attachment site before attaching

the probe. If there is nail polish on the attachment

site, remove the polish. Otherwise, the amount of

transmitted light decreases, and measured value

may be incorrect or measurement cannot be

performed.

CAUTION

If the skin gets irritated or redness appears on

the skin from the probe, change the attachment

site or stop using the probe. Take extreme care

for the patients with delicate skin.




1. GENERAL

CAUTION

• If the probe is attached to the same limb that

is used for NIBP measurement or an IBP

catheter, the blood circulation at the attachment

site is affected and the measurement might not

be correct. Attach the probe to a limb where the blood

circulation is not affected.

• If patient’s nail is long, cut it or attach the probe

to another finger. The probe cannot be attached

properly to a finger with a long nail.

• Refer to the probe instruction manual for

details.

CAUTION

Remove the probe carefully and slowly from

the skin. The adhesion may damage the skin.

Especially when removing it from a neonate,

pay attention to the neonatal skin because it is

delicate.

CAUTION

When removing the probe from the attachment

tape, do not pull the sensor cable because this

can damage the cable.

CAUTIONWhen the probe is attached on an appropriate

site with sufficient circulation and the error

message confirming the probe attachment

repeatedly appears, the probe may be

deteriorated. Replace it with a new one.

CAUTIONWhen a message indicates a faulty probe or

faulty SpO2 connection cable, replace the probe

or SpO2 connection cable with a new one.

CAUTION

While a patient is on medication which causes

vasodilation, the pulse waveform may change

and in rare cases the SpO2 value might not be

displayed.

CAUTION

• Do not use creosol soap, glutaraldehyde,

sodium hypochlorite, or benzalkonium chloride

because they damage the probe.

• Do not soak the probe in cleaning solution

because it is not waterproof.

CO2 Monitoring

WARNING

When performing defibrillation during CO2

monitoring with a CO2 sensor kit, remove the

sensor from the patient. If the sensor cannot be

removed, do not touch the sensor cable because

the discharged energy may cause electrical

shock or injury.

WARNING

With the TG-901T3 CO2 sensor kit,

measurements are based on the assumption

of no CO2 gas in the inspiration. The CO2

concentration in the respiration is calculated by

taking the CO2 concentration in the inspiration

as 0 mmHg. Therefore, measuring CO2 by

connecting the CO2 sensor kit to a patient under

mouth-to-mouth respiration or to a Jackson Rees

circuit or Mapleson D circuit where CO2 gas may

be present during inspiration may result in the

acquired data being lower than the actual value.

WARNING

With the TG-901T3 CO2 sensor kit, this

defibrillator cannot monitor CO2 of patients

weighing less than 10 kg (22 lbs).



1


1. GENERAL

CAUTION

The CO2 data may be inaccurate when

monitoring a patient with an extremely high

respiration rate or irregular respiration. Read the

measured values carefully.

CAUTION

The measured value may be incorrect when the

operating temperature changes greatly or there

is excess condensation in the airway adapter or

nasal adapter.

CAUTION

When the “CO2 sensor not working” or “CO2

adapter abnormality” message is displayed,

check the CO2 sensor kit and replace it if

necessary. CO2 cannot be monitored while the

message is displayed.

CAUTION

Follow the CAUTION label on the CO2 gas

cylinder.

CAUTION

When using an anesthetic instrument with a

volatile anesthetic agent, the CO2 measurement

may be inaccurate.

CO2 Sensor Kit and Airway Adapter

WARNING

Do not use the airway adapter on neonates

because the dead space volume of the airway

adapter is about 5 mL.

WARNING

When using the YG-101T airway adapter on a

patient with low ventilatory volume, check the

ventilation taking into consideration the 5 mL

dead space. The CO2 may mix in the inspiration

due to the airway adapter s dead space, resulting

in inaccurate measured value or difficulty in

detecting apnea.

WARNING



ventilation taking into consideration the 1.2 mL


due to the airway adapter’s dead space, resultingin inaccurate measured value or difficulty in

detecting apnea.

WARNING

• When you use YG-122T together with an

oxygen cannula, check that the oxygen cannula

is correctly attached on the patient by referring

to other parameters and by observing the

patient periodically.• If arterial oxygen partial pressure does not

increase, immediately stop using the oxygen

cannula with the CO2 sensor kit and select

another way to supply oxygen.




1. GENERAL

WARNING

The only oxygen cannula that can be used with

YG-122T is #1103 manufactured by HUDSON

RCI ® . Do not use any other oxygen cannula.

Other oxygen cannulas cannot be attached and

oxygen cannot be delivered to the patient throughthe nostrils.

WARNING

Check that the oxygen cannula tube is not bent,

broken, or blocked by the nasal tube. If the ends

of the oxygen cannula tube turn too far up or

down, it causes insufficient O2 supply or the CO2

value may be incorrect.

CAUTION

The airway adapter/nasal adapter is non-

sterilized and disposable. Use only for a single

patient and single use. Failure to follow this

instruction causes cross infection.

CAUTION

With the TG-901T3 CO2 sensor kit, secure the

CO2 sensor to the respiration circuit so that

the transparent film of the airway adapter is

perpendicular to the floor. If the transparent film is

parallel to the floor, water droplets may get onto

the transparent film and affect the measurement

accuracy.

CAUTION

Failure to follow the instructions below degrades

the anti-fogging ability of the transparent film and

results in incorrect measurement.

• Replace the airway adapter/nasal adapter with

a new one every 24 hours.


a new one if blood, sputum or mucus adhere to

the transparent film.

• Do not damage the transparent film. Do not let

dust or detergent contact the transparent film.

Do not touch, wipe or clean the transparent film

with fingers or cleaners.

CAUTION

Never autoclave or perform EOG gas sterilization

for the TG-901T3 CO2 sensor kit. It damages the

CO2 sensor kit and safety cannot be guaranteed.

CAUTION

When using the YG-121T/YG-122T nasal adapteron a patient with bleeding disorder, poor general

medical condition or malnutrition, observe the

patient condition all the time. The mouth guide

touches the mouth and may cause pressure

sores.

Alarms

WARNING

During alarm suspension (“Alarm off” or “Alarm

suspended” message displayed), all current

alarms except for instrument alarm group 1 are

turned off. Be careful when you suspend the

alarm.

WARNING

When admitting a new patient, check the alarm

settings.

CAUTION

When the alarm limit is set to OFF, there will be

no alarm for that limit. Be careful when you set

the alarm limit to OFF.

CAUTION

Alarms about a parameter do not occur until the

measurement of the parameter starts.



1


1. GENERAL

Maintenance

WARNING

When performing energy discharge check,

keep the paddles in the paddle holders. Do not

discharge with the paddles in the air or touching

the patient. When checking paddles other than

the external paddles, use a defibrillator analyzer

or other checking equipment.

WARNING




WARNING





• Replace the battery pack every two years.• If defibrillation or cardioversion is necessary





CAUTION

Before maintenance, cleaning or disinfection,

turn the defibrillator power off, disconnect the

power cord from the AC socket and then remove

the battery from the defibrillator. Failure to follow

this instruction may result in electrical shock and

defibrillator malfunction.

CAUTION




shock.

CAUTION

Assembly and disassembly of any component in

the instrument should only be done by qualified

service personnel.

Storage

CAUTION

To prevent overheating, leave the defibrillator

lying flat and do not cover it.

CAUTION

Store the disposable pads in the environment

described on the pads package. If stored in

an environment other than specified, the pads

become unusable.




1. GENERAL

Recording Sound

Surrounding sound and ECG waveforms can be recorded in an SD card in the

debrillation screen, AED screen, pacing screen and monitoring screen. Up to

2 hours of sound recording is available with the QM-001D (1 GB) SD memory

card. You can save report data in the SD card (refer to “Save Report” in Section

3). When the SD card is inserted into the debrillator, recording automatically

starts.

To stop recording,

1. Turn the Energy/Mode Select control to the SETUP position to open the

Setup screen.

2. When the “Can eject SD card” mark appears at the upper corner of the

screen, remove the SD card by pushing it in.

CAUTION

Only remove the SD card in the Setup screen. Otherwise, the saved

data may be damaged. When the SD card is removed after the

power is turned off, the latest 30 seconds of data is lost.

To play back the recorded sound and ECG waveforms, refer to “Use Voice File”

in Section 3.




2

Location ...............................................................................................................................................................2.2

Surrounding Conditions .............................................................................................................................2.2

Radiofrequency or Electromagnetic Field .................................................................................................2.2

Power ................................................................................................................................................................... 2.3

AC Operation ............................................................................................................................................. 2.3

Battery Operation ......................................................................................................................................2.3

Using AC Power...................................................................................................................................................2.4

Connecting the Power Cord ......................................................................................................................2.4

Cutting Off the Power Supply to the Defibrillator .......................................................................................2.4

Using the Battery .................................................................................................................................................2.5Safety Information about Battery Pack ......................................................................................................2.5

Checking the Battery Pack ..............................................................................................................2.7

Storage ............................................................................................................................................ 2.7

Disposal ..........................................................................................................................................2.7

Inserting the Battery into the Defibrillator ..................................................................................................2.8

Charging the Battery Pack ........................................................................................................................2.9

Trickle Charging ....................................................................................................................................... 2.10

Remaining Battery Power Display ...........................................................................................................2.11

Loading the Recording Paper ............................................................................................................................2.12

Basic Checks .....................................................................................................................................................2.13Displaying the Basic Checks Screen ....................................................................................................... 2.13

Check Procedure ..................................................................................................................................... 2.13

Check Before Use..............................................................................................................................................2.16

Before Turning On the Power ..................................................................................................................2.16

Check Items After Turning the Power On ................................................................................................2.17

Section 2 Preparation




2. PREPARATION

Location

WARNING

Never use the defibrillator in the presence of any flammableanesthetic gas or high concentration oxygen atmosphere. Failure to

follow this warning may cause explosion or fire.

WARNING

Never use the defibrillator in a hyperbaric oxygen chamber. Failure to

follow this warning may cause explosion or fire.

Surrounding Conditions

WARNING

Fluids such as Ringer’s saline solution and blood are excellent

electrical conductors; to avoid creating potentially dangerous

electrical paths, keep the defibrillator and the immediate area clean

and dry at all times.

Radiofrequency or Electromagnetic Field

WARNING

Do not use any kind of non-essential non-patient care device within

a radius of 1 meter around the defibrillator. The use of non-essential

non-patient care devices that emit radiofrequency or electromagnetic

fields may interfere with the operation of the defibrillator by causing

noise on the ECG waveform or error messages. If a non-essential

non-patient care device is accidentally placed near the defibrillator,

quickly remove it.

WARNING

Do not take this defibrillator into the MRI test room. This defibrillator

is not designed to be used during MRI tests.



2


2. PREPARATION

Power

WARNING

Only use the provided power cord. When the provided power cordcannot be used or when equipotential grounding is doubtful (such as

in poor grounding facility), operate the defibrillator on battery power.

Otherwise, the patient and operator may receive electrical shock or

injury.

The debrillator can operate on either battery or AC power. You can select

either AC or battery (battery pack NKB-301V: option) according to where the

debrillator is used.

AC Operation

When the power cord is plugged into an AC outlet, the AC lamp lights. When the

debrillator power is turned on with the power cord connected to an AC outlet,

the debrillator operates on AC power. The “ ” mark is displayed on the right

upper screen.

Battery Operation

When the battery is inserted and the power cord is disconnected, such as when

transferring a patient, the debrillator automatically switches to battery power.

The “ ” mark is displayed on the screen.

The battery can be charged only by the debrillator. The battery is charged when

the power cord is plugged into an AC outlet and AC power is supplied to the

debrillator. The battery is also charged during operation.

NOTE

For the TFT LCD screen, it is considered normal if some pixels have

randomly abnormal color or do not light.




2. PREPARATION

Using AC Power

Connecting the Power Cord

WARNINGOnly use the provided power cord. Using other power cords may

result in electrical shock or injury to the patient and operator.

Connect the provided power cord to the AC SOURCE socket on the rear panel

of the debrillator and plug the cord into a 3-prong AC outlet. When the 3-prong

power cord is connected to the 3-prong AC outlet with a ground third contact, the

debrillator is automatically grounded.

When AC power is supplied to the debrillator, the AC lamp lights.

NOTE

If the AC lamp does not light when the power cord is connected, check if

the power cord is properly connected.

Cutting Off the Power Supply to the Defibrillator

To cut off the power supply to the debrillator, disconnect the power cord of the

debrillator from the wall AC outlet. When installing the debrillator, position

the debrillator so that it is easy to disconnect the power cord from the wall AC

outlet.



2


2. PREPARATION

Using the Battery

NOTE

• The battery lifetime is two years. Replace the battery pack within two

years after the first use.- Replacing the battery 18 months after the first use is recommended.

- When the battery pack is frequently used, the battery life may

become shorter than 18 months.

- Do not use an expired battery pack. The defibrillator may malfunction

and safety is not guaranteed.

• Before operating the defibrillator on battery, check the label on the

defibrillator for the date the battery was first used.

• In order to ensure emergency use of the defibrillator on battery power,

perform the battery test once a month.

When the battery pack NKB-301V (option) is inserted in the debrillator

and the debrillator is not connected to AC power, the debrillator can be

operated on battery. When the power cord is disconnected during AC operation,

the debrillator automatically switches to battery operation, which enables

continuous operation. When the power cord is connected again, the debrillator

switches to AC operation automatically.

With the fully charged new battery at 20°C, the debrillator can perform:

Debrillation: at least 70 discharges at 270 J

Monitoring: at least 150 minutes continuous monitoring

Noninvasive pacing: at least 90 minutes pacing in FIXED mode at 180 ppm

and 200 mA

With the fully charged new battery at 0°C, the debrillator can perform:

Debrillation: at least 50 discharges at 270 J

Safety Information about Battery Pack

WARNINGDo not do the following to the battery. It may

cause leakage, overheating, explosion and fire.

• Short-circuit the + and – terminals on the

battery.

• Put the battery into fire or heat the battery.

• Disassemble or modify the battery.

• Give strong impact to or deform the battery.

• Use the battery on unspecified instruments.

• Charge the battery on unspecified instruments.

• Install the battery with the wrong polarity.

• Leave the battery in the reach of patients.

WARNINGIf the battery pack is damaged and the substance

inside the battery pack contacts the eyes or skin,

wash immediately and thoroughly with water and

see a physician. Never rub your eyes, because

you may lose your eyesight.




2. PREPARATION

WARNING





• Replace the battery pack every two years.• If defibrillation or cardioversion is necessary





WARNING

• Do not immerse the battery pack in water.

The battery may overheat and rust and the

substance inside the battery may leak.

• Do not leave the battery pack unused for more

than about one year. The battery may leak.

CAUTION




shock.

CAUTION

To keep the battery pack fully charged, always

keep the power cord connected to the AC

outlet even when the defibrillator is not used.

Otherwise, the battery pack may discharge and

become unusable.

CAUTION

Do not expose the battery pack to direct sunlight

or leave in a high temperature place. The

lifetime of the battery pack may be shortened,

the performance of the battery pack may be

degraded and the battery may leak.

CAUTION

The battery pack must be replaced by qualified

service personnel.

CAUTIONDo not leave the battery pack near the patient or

in reach of children.

NOTE

• Fully charge the new battery pack before using on the defibrillator.

• Do not use a battery pack which is past the expiration date written on

the label.

• If the battery pack becomes unusable or the available discharge time

has decreased, do not leave the battery pack in the defibrillator. The

substance inside the battery may leak, causing instrument corrosion

and fire. Immediately replace the battery with a new one.

• Do not leave a battery pack inside the defibrillator without the power

cord connected between the defibrillator and AC outlet. The battery

pack may be over-discharged and can no longer be used.

• When not using the defibrillator for more than six months, remove the

battery pack from the defibrillator and store the battery at temperatures

between −20°C (−4°F) and +35°C (+95°F) and low humidity.

• Before disposing of the defibrillator, make sure that the battery pack is

removed from the defibrillator.



2


2. PREPARATION

• Before disposing of the battery, check with your local solid waste

officials for details in your area for recycling options or proper disposal.

The battery is recyclable. At the end of its useful life, under various

state and local laws, it may be illegal to dispose of this battery into the

municipal waste stream.

Checking the Battery Pack

NOTE

In order to ensure emergency use of the defibrillator on battery power,

perform the battery test once a month.

To prevent battery trouble, check the battery appearance every 6 months. If there

is any damage (crack, deformation, cable discontinuity and so on) on the battery

or the battery leaks, replace the battery with a new one. If the battery is dirty with

dust, remove it.

Storage

WARNING

Do not immerse the battery pack in water. The battery may overheat

and rust and the substance inside the battery may leak.

• When not using the debrillator for more than one month, to prevent leaking or

rusting of the battery, remove the battery pack from the debrillator and store

the battery at surrounding temperatures between −20°C (−4°F) and +35°C

(+95°F) and low humidity.

• When a battery is not used for over one month, fully charge it before use. Even

if the battery was fully charged before storage, the battery self-discharges and

operation time decreases.

• To ensure full performance of the debrillator, replace the battery every two

years. Replacing the battery 18 months after the rst use is recommended.

• When a battery is stored for a long time, the battery tends to deactivate and the

original battery capacity cannot be used to 100%. The capacity may recover by

repeating full discharging and full charging several times.

Disposal

The battery is NiMH. Before disposing of the battery, check with your local solid

waste ofcials for details in your area for recycling options or proper disposal.

The battery is recyclable. At the end of its useful life, under various state and

local laws, it may be illegal to dispose of this battery into the municipal waste

stream.




2. PREPARATION

Inserting the Battery into the Defibrillator

Before inserting the battery, check the battery appearance and write the date of

rst use on the label on the battery. After inserting the battery, charge the battery.

NOTE

• Use only the battery pack NKB-301V.

• Perform the battery test once a month. Check the battery appearance

every 6 months. Replace the battery every two years. Replacing the

battery 18 months after the first use is recommended.

• The battery pack must be inserted by a qualified service personnel.

1. Before inserting the battery into the debrillator, write the date of the rst

use on the label on the battery.

2. Conrm that the Energy/Mode Select Control is set to OFF. Disconnect the

power cord from the debrillator.

CAUTION

When inserting or removing the battery pack, disconnect the power

cord from the defibrillator. Otherwise, the operator may receive

electrical shock.

3. Turn the knob on the battery pack holder cover counterclockwise and

remove the battery pack holder cover.

4. Insert the battery into the battery pack holder.

5. Securely connect the battery connector to the connector inside the battery

pack holder until it clicks and locks.

6. Close the battery pack holder cover. Be careful not to pinch the cable. Secure

the battery pack holder cover by turning the knob clockwise.

7. On the battery check label*, write the date of battery rst use and the date

the battery is checked. On the start date label**, write down the date of

battery rst use. Attach each label on the debrillator so that you can see

them easily, for example, on the upper part of the right side panel.

* Debrillator standard accessory

** Battery standard accessory



2


2. PREPARATION

8. Reset the date of rst use of the battery.

i) Display the System Setup - Battery Test screen.

ii) Press the Reset key to reset the date of rst use of the battery. The “Time

to replace battery” message appears two years after the Reset key is

pressed.

NOTE

You must do this step when the battery is replaced. Otherwise, the

defibrillator does not display the “Time to replace battery” message to

prompt you to replace the battery.

Charging the Battery Pack

The battery can be charged by the debrillator or a specied battery charger.

When “ 0 ” appears on the screen, immediately charge the battery. When

“ 0 ” is displayed on the screen, the debrillator cannot charge the debrillation

or cardioversion energy. The battery pack is not fully charged at the factory.

NOTE

• When you use a new battery, charge the battery at least 3 hours until

the battery charge complete lamp lights.

• Always charge the battery pack at surrounding temperatures between

0°C (32°F) and 40°C (104°F). Charging may stop when the battery

is charged at surrounding temperatures higher than 45°C (113°F). In

this case, move the defibrillator to a cooler place. When the battery

temperature decreases, the battery charging resumes.

• Charge the battery pack only by the defibrillator or the specified

battery charger. If the battery pack is charged with another instrument,

abnormal current flows, the substance inside the battery may leak and

the battery may explode. It also causes defibrillator malfunction and

instrument trouble.

• When charging the battery using the defibrillator, confirm that the

AC lamp is lit and either the battery charging lamp or battery charge

complete lamp is lit.

• Charge the battery pack immediately after it is used. If it is left

uncharged, the battery will become unusable because of over-

discharge.

Charging procedure

1. Set the Energy/Mode Select control to the OFF position.

2. Connect the power cord to the debrillator. The battery charging lamp on the

front panel lights and the charging (rapid charging) starts.

NOTE

Do not disconnect the power cord until charging finishes.

3. When rapid charging nishes, the battery charge complete lamp lights.




2. PREPARATION

NOTE

• When the battery charging lamp continues to be lit over 5 hours (the

battery charge complete lamp does not light), the battery is abnormal.

Perform battery test and if the battery proved to be abnormal, replace it

with a new one.

• Blinking battery charging lamp indicates that the temperature inside the

defibrillator is rising. In this case, immediately quit charging. Move the

defibrillator to a cool place and start charging again. Charging starts

after the temperature inside the defibrillator decreases.

Trickle Charging

After battery charge complete lamp lights, keep the power cord connected to

the AC outlet regardless of whether the debrillator is used or not. The trickle

charge* starts in order to keep the battery fully charged.

* Trickle charge is a method to charge with small current to compensate for the

loss by self discharge. This prevents the decrease of battery capacity caused by

self discharge.

CAUTION

To keep the battery pack fully charged, always keep the power cord

connected to the AC outlet even when the defibrillator is not used.

Otherwise, the battery pack may discharge and become unusable.

NOTE

• When the defibrillator operates on a fully charged battery and “ ”,

“ 1 3 ” or “ 0 ” appears soon, the battery is deteriorated. Check the

capacity by the battery test. If a “Battery WEAK” or “Replace battery”

message appears, replace the battery with a new one.

• Perform the battery test once a month.



2


2. PREPARATION

Remaining Battery Power Display

When the debrillator operates on battery, the remaining battery power is

displayed on the top right of the screen. When a message appears, an alarm

sounds.

Mark Message Remaining Battery PowerAvailable discharges

(20°C, 270 J charge) — Remain enough 40 discharges or more

Battery discharged* Remain about 2/3 About 20 to 40 discharges

Battery discharged* Remain 1/3 or less About 4 to 20 discharges

1 3

Charge battery Battery is discharged. Replace the

battery with a charged battery or

switch to AC operation.

3 discharges or less

0

Charge battery Cannot operate on battery. The

power turns off soon. Replace the

battery with a charged battery or

switch to AC operation.

Not available

* The message disappears after 5 or 6 seconds.

NOTE

• The values in the table are under the condition that the battery is

handled as specified in this manual. The value is affected by the battery

usage and storage conditions. While the recorder is running, the

operation time is shorter than indicated in the table.

• The defibrillator cannot charge energy when the battery mark is

blinking. Immediately connect the defibrillator to AC power or replace

the battery with a fully charged one.

• When using a battery that is not fully charged, the remaining battery

power display may be incorrect.




2. PREPARATION

Loading the Recording Paper

NOTE

Only use the FQS50-2-100 Z-fold type recording paper.

1. Pull the door release lever of the recorder up to open the door. For safety, the

door stops half-open. Pull the door completely down with your hand.

2. Set the recording paper inside the recorder with the printed side up.

To load Z-fold recording paper, rst pull the slide plate toward you until it

clicks and load the paper.

3. Draw out the paper toward you and close the door until it clicks.

4. Press the Record key on the front panel to feed the recording paper.



2


2. PREPARATION

Basic Checks

With the basic checks, the following six or seven functions are checked

depending on the debrillator model. Perform the basic checks everyday.

• Discharge check

• Battery check

• Recorder check

• Alarm check

• Voice check

• Pacing check (TEC-5531 only)

• Debrillation waveform check

Displaying the Basic Checks Screen

Turn the Energy/Mode Select control to the BASIC CHECK position. The Basic

checks screen appears.

Check Procedure

WARNING

When performing energy discharge check, keep the paddles in

the paddle holders. Do not discharge with the paddles in the air or

touching the patient. When checking paddles other than the external

paddles, use a defibrillator analyzer or other checking equipment.

NOTE

• When the Basic checks screen is displayed, the waveform is

automatically switched to TEST and the patient ECG waveform is not

monitored. To monitor the patient, finish the basic checks or turn the

Energy/Mode Select control to the MONITOR position.

• Do not continuously perform the basic checks more than the specifiednumber of charge/discharge cycles. Refer to “Specifications -

Defibrillator - Maximum continuous charge/discharge cycles at 270 J” in

Section 11.

VF/VT :

In the Basic checks screen,

the VF/VT detection function is

automatically turned off.




2. PREPARATION

When you start basic checks, all items are checked automatically. Follow the

instruction on the screen and press the corresponding key.

Results are displayed in the right column for each item as “ ”(pass) or “ ”

(fail). When all items are nished, the results are recorded on the recording

paper. For failed items, the debrillator may be faulty. Contact your Nihon

Kohden representative.

1. Press the OK key to start basic checks. Discharge check starts. Press the

Cancel key to cancel the item which is currently checked and start checking

the next item.

i) Discharge check

Energy charging starts. The CHARGE lamp blinks, there is a beeping

sound and a “CHARGING **J” message is displayed on the screen.

When charging completes, the CHARGE lamp lights and there is a

continuous buzzing sound. Conrm that “270 J” and “CHARGED”

messages appear on the screen. Then, the “Press discharge buttons until

discharge” message appears. With the paddles in the paddle holder,

simultaneously press both DISCHARGE buttons on the external

paddles. Hold the buttons pressed until energy is discharged to the

paddle holders. The energy is discharged in synchronization with the

TEST waveform.

Check that the displayed energy value becomes “J” and “ ” is

displayed on the screen.

Recording example of the discharge check

ii) Battery check

Check that “ ” is displayed on the screen.

iii) Recorder check

A “Did the recorder print?” message is displayed on the screen. Press

the Yes key when paper was output, and the No key when paper was not

output.

iv) Alarm check

A “Did the alarm sound?” message is displayed. Press the Yes key whenthe alarm sounded, and the No key when the alarm did not sound.



2


2. PREPARATION

v) Voice check

A “Was the voice heard?” message is displayed and there is a voice “Use

disposable paddle”. Press the Yes key when the voice was heard, and the

No key when the voice was not heard.

vi) Pacing check

NOTE

• Check that the external paddles are properly placed on the

paddle holders and that the external paddle connector is firmly

connected to the paddle connector. Otherwise, the pacing check

does not start. During the pacing check, if an external paddle

is removed from the paddle holder or the external paddle

connector is disconnected, the pacing check stops. When the

external paddle is returned to the paddle holder or the external

paddle connector is reconnected, the green paddle contact

lamp lights and 5 seconds later the pacing check resumes at

50 mA pacing current.

• During this check, QRS synchronization point is not displayed.

This check is only available for the TEC-5531 Series Debrillator. The

pacing monitor in the debrillator checks the eight pacing pulses output

from the external paddles. The check is performed by changing the

pacing current as follows.

Pacing mode: xed

Pacing rate: 120 ppm (xed)

Pacing pulse: 50 → 100 → 150 → 200 mA

The detected pacing pulse is displayed with an “*” mark for each

current.

2. When all checks nish, a “Basic checks complete” message appears on the

screen and the check result is recorded on the recording paper.

If a “Use another instrument” message appears, stop using the debrillator

and contact your Nihon Kohden representative. If any item fails, contact

your Nihon Kohden representative.

3. Debrillation waveform check

The debrillation waveform that is output in the Discharge

check can be displayed by pressing the Wave shape key. To

return to the Basic check menu, press the Return key.

NOTE

• On the Basic checks screen, if the Energy/Mode Select

control is set to positions other than BASIC CHECK,

the Basic checks screen immediately closes and

switches to the screen of the selected mode.

• Make sure that the time printed on the recording paper

is correct. The date and time on the recording paper

are important information of the medical record.




2. PREPARATION

Check Before Use

Before use, do the following checks to conrm that the debrillator is in normal

condition and can be used safely. If there is any abnormality, take appropriate

remedial actions referring to Section 10 “Maintenance”. If the debrillator seems

to be faulty, attach a “Not available” or “Repair request” label on the debrillator

and contact your Nihon Kohden representative.

Before Turning On the Power

Before turning on the power, check the following items.

Accessories

• Paddles, pads and cables prepared

• Sufcient recording paper

• Sterilized internal paddle electrode prepared, if necessary

• Sufcient disposable pads, if necessary

• Sufcient contact gel (GELAID)

• Sufcient number of disposable electrodes

Connection and Setting

• Specied 3-prong power cord and ground lead are properly connected.

• Recording paper is loaded.

• Battery is fully charged (battery charge complete lamp is lit).

Overview

• Debrillator is not dirty, rusted, damaged or in contact with liquid.

• External paddles and paddle holders are not dirty or rusted.

• Operation panel is not torn or broken.

• All keys, buttons and control are undamaged and function properly.

• Power cord, cables and pins of the paddle connector are not frayed or

damaged.



2


2. PREPARATION

Check Items After Turning the Power On

Power on

• The AC lamp lights when the power cord is connected to the debrillator.

• There is no re, smoke or smell.

• There is no electrical shock when touching the debrillator.

• Debrillator is not abnormally hot.

• Debrillator does not affect surrounding equipment.

Basic operation

• The screen display is correct. (brightness, distortion)

• Lamp indication is correct.

• All keys, buttons and control operate properly.

• All settings are correct.

• The battery is fully charged.

• No abnormality is found in the basic checks. (no abnormality in charging/

discharging, battery, recorder, alarm sound, voice and pacing check)

• Time printed on the recording paper is correct.

• Alarm functions properly.

• The paper is fed correctly. (no wandering or jam)

• Recorded waveforms and letters are clear.

• There is no error message or abnormal operation.

Alarm

• Alarm settings are correct.

NOTE

Make sure that the date and time printed on the recording paper is

correct. The date and time on the recording paper are important parts of

the medical record.




3

Section 3 System Setup Screen and

Setup Screen

System Setup Screen ..........................................................................................................................................3.3

Changing the Items on the System Setup Screen ....................................................................................3.3

Configuration .............................................................................................................................................3.4

Setting List ......................................................................................................................................3.5

Setting Description ..........................................................................................................................3.7

Battery Test .............................................................................................................................................3.12

HV Capacitor Test....................................................................................................................................3.12

Recorder Test .......................................................................................................................................... 3.12

System Information .................................................................................................................................3.13

Report History .........................................................................................................................................3.13Use Voice File .......................................................................................................................................... 3.13

Setup Screen .....................................................................................................................................................3.15

Setup Item List ........................................................................................................................................3.15

Changing the Settings on the Setup Screen ...........................................................................................3.16

Paddle Setup ...........................................................................................................................................3.16

ECG Setup ..............................................................................................................................................3.16

SpO2 Setup .............................................................................................................................................. 3.16

CO2 Setup ...............................................................................................................................................3.16

Report Setup ...........................................................................................................................................3.17

Recorder Setup .......................................................................................................................................3.17Date/Screen ............................................................................................................................................3.17

Date and Time ............................................................................................................................... 3.17

2nd Wave ......................................................................................................................................3.18

QRS Setup ..............................................................................................................................................3.18

Alarm Setup ............................................................................................................................................3.18

Save Report ............................................................................................................................................3.19




3. SYSTEM SETUP SCREEN AND SETUP SCREEN

You can change the hardware and software settings on the Setup screen and

System Setup screen. The System Setup screen also provides the hardware check

functions.

When a Setup or System Setup screen is opened, the ECG lead key, ECG

sensitivity key, Silence alarms key and Multi-function key become the function

keys for the functions on the screen which are displayed above each key.

NOTE

• Defibrillation, cardioversion and pacing are not available while the

Setup screen or System Setup screen is displayed.

• Setting items on the System Setup screen and checking the hardware

must be performed by the administrator of this defibrillator at your

hospital or by a person with medical and technical knowledge.





3

System Setup Screen

Changing the Items on the System Setup Screen

Turn the Energy/Mode Select control to the SETUP position while pressing and

holding the Silence alarms key. Hold the Silence alarms key until the System

Setup - Menu screen appears.

About the System Setup - Menu screen

1. Conguration

This changes system settings.

2. Battery Test

This checks the built-in battery performance to conrm safe battery

operation.

3. HV Capacitor Test

This checks the performance of the HV (high voltage) capacitor to charge

the energy for debrillation and cardioversion.

4. Recorder Test

This checks the built-in-recorder with preset waveforms and alphanumeric

characters.

6. System Information

This shows system information.7. Report History

This records information for maintenance.

9. Use Voice File

Plays the recorded sound from an SD card.

• To select the item, press the Item key and press the OK key. The selected

screen opens.

• To exit the System Setup screen, turn the Energy/Mode Select control to any

position other than SETUP.

NOTE

The changed settings are immediately applied when they are selected. If

you want to return a setting to its previous value, set the setting again.





Configuration

This changes system settings.

1. On the System Setup - Menu screen, select “1. Conguration” with the Item

key.

2. Press the OK key. The System Setup - Conguration screen appears.

You can print the hard copy of the currently displayed System Setup screen

by pressing the Record key.

3. Press the Item ↓ or Item ↑ key to select an item. The selected item is

highlighted. If the desired item is not on the current screen, scroll the screen

with the Item ↓ or Item ↑ key.

4. Press the Select key to select the setting. Every time the Select key is

pressed, the setting is changed.

To return to the System Setup - Menu screen, press the Menu key.





3

Setting List

The factory default settings are underlined.

No. Parameters Description Settings

1 AED Energy

Select the 1st, 2nd and 3rd energy in

AED mode. The number of charges for

one sequence in AED mode is set in “5.

Discharge/AED sequence”.

2, 3, 5, 7, 10, 15, 20, 30, 50, 70,

100, 150, 200, 270 (J)

(Default setting: 150 for 1st, 200

for 2nd, 270 for 3rd)

2 Energy after 3rd discharge

After the 3rd discharge, repeat the entire

energy cycle (1st → 2nd → 3rd → 1st…)

or repeat the 3rd energy (1st → 2nd → 3rd

→ 3rd…).

Repeat cycle, 3rd energy

3 AED button First Analysis

Select whether or not to start AED

analysis by pressing the CHARGE/AED

button when AED mode is selected.

ON: Press the CHARGE/AED

button to start AED analysis.

OFF: When AED mode is

selected AED analysis is

automatically started.

4AED button 2nd or later

Analysis

After each discharge, select whether

manually or automatically start AED

analysis.

Each shock, Each Seq., OFF

5 Discharge/AED sequence Number of discharges for one sequence in

AED mode1, 2, 3, 4

6 CPR time (s)Wait time until starting AED analysis in

background after one sequence.

30, 60, 90, 120, 150, 180, 210 (s),

OFF

7 CPR timing soundDuration of CPR timing sound in AED

mode

60, 70, 80, 90, 100, 110, 120 (s),

OFF

8 Pause TimePause time to temporarily pause

background AED analysis in AED mode.30, 60, 120, 180 (s)

9 Manual deb conrmation Select the conrmation method to enter

manual debrillation mode. None, Conrm, Password

10 Password Password to enter manual debrillationmode Four digit password from 1, 2, 3, 4(Default setting: 1111)

11 Charge holding time (s)Duration to hold energy after charging is

complete.30, 40, 50, 60 (s)

12 Sync mode after CV

Select operation mode after synchronized

cardioversion. You can continue

synchronized cardioversion mode (Sync)

or return to debrillation mode (Deb).

Sync, Deb

13 Check Pulse Pattern Select when the debrillator should check

the pulse.

1: After discharge, after no

shockable rhythm and after CPR

2: Only after CPR

3: Do not check pulse

4: Do not check pulse. VF/VTdetection off during CPR.

14 ID

Five digit ID number for this debrillator.

The ID number is printed on the recording

paper.

Valid characters:

0 to 9, a to z, A to Z, . , - , :, space,

Default setting: serial number

15 Power on lead Select lead the when the power is on. PADDLE, II

16 ECG leads Select available ECG leads. 3 LEAD, 5 LEAD

17 ECG, SpO2 sweep speedECG and SpO2 waveform sweep speed on

the screen25, 50 (mm/s)

18 CO2 sweep speed (mm/s) CO2 waveform sweep speed on the screen 6.25, 12.5 (mm/s)

19 Alarm SettingSelect the alarm settings when the power

is on.Latest, Default

20 Alarm sound Vital alarm sound type Cont tone, Beeping

21 Alarm Volume Alarm sound volume. 1, 2, 3, 4

22 Charge Sound Volume Charge sound volume. 1, 2, 3, 4

23 Voice Prompt Volume Voice prompt volume. 1, 2, 3, 4, OFF





No. Parameters Description Settings

24 Delayed recordingSelect whether or not to perform delayed

recording.ON, OFF

25 Alarm recordingSelect whether or not to perform automatic

recording on vital alarm occurrence.ON, OFF

26Record on charging after

discharge

Select whether or not to perform automatic

recording when energy charging starts.ON (6 s), ON (12 s), OFF

27 Record CAL waveSelect whether or not to record the CAL

waveform in manual recording.ON, OFF

28 Paper speed (mm/s) Paper speed of the recorder 25, 50 (mm/s)

29 Periodic recording interval (min)Select the interval when periodic

recording is set to FREE.

1 to 9, 10, 20, 30, 40, 50, 60, 70,

80, 90, 100, 110, 120 (min)

30 Printing character sizeCharacter size printed on the recording

paper Large, Small

31 Date format Date format

YYYY/MM/DD

MMM/DD/YYYY

YYYY/MMM/DD

DD/MM/YYYY

32 MedicationSelect whether or not to display themedication function keys when the Event

key is pressed.

ON, OFF

33 AC line frequency

AC line frequency. This setting is

important to reduce artifact in SpO2

measurement.

50, 60 (Hz)

34 TEST leadSelect whether or not TEST lead can be

selected.ON, OFF

35 Pressure units Units used in CO2 measurement mmHg, kPa

36 Pacing Current StepsSelect the step to increase or decrease the

pacing current.1, 2, 5, 10 (mA)

37 Pacing Power on Settings Select the pacing current and pacing ratesettings when the power is on. Default, Latest

38 — — —

39 Load Settings

Select “OK” to load the system setup

settings and setup settings from the SD

card.

OK, OFF

40 Save Settings Select “OK” to save the system setup

settings and setup settings in the SD card.OK, OFF

41 Format Card Select “OK” to format the SD card. OK, OFF

42 System initialize Initializes all System Setup settings. OK, OFF





3

Setting Description

The factory default settings are underlined.

1. AED Energy

Select the rst, second and third energy in AED mode. The selected energy is

automatically charged when a shockable waveform is detected. The number

of discharges for one sequence in AED mode is set in “5. Discharge/AED

sequence”.

Selection list: 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200, 270 J

2. Energy after 3rd discharge

Select the energy after the third discharge in AED mode.

Repeat cycle: The rst energy is selected.

3rd energy: The third energy is selected.

Repeat cycle:

After the third discharge, the energies of the rst, second and third discharge

are repeated.

(Example)

1st: 150 J

2nd: 200 J

3rd: 270 J

4th: 150 J (same as the 1st energy)

5th: 200 J (same as the 2nd energy)

6th: 270 J (same as the 3rd energy)

7th: 150 J (same as the 1st energy)

:

3rd energy:

The energy after the third discharge is the same as the energy of the third

discharge.

(Example)

1st: 150 J

2nd: 200 J

3rd: 270 J





:

3. AED button First Analysis

When AED mode is selected, select whether or not to start AED analysis

(shockable waveform detection) by pressing the CHARGE/AED button.

ON: Press the CHARGE/AED button to start AED analysis in AED mode.

OFF: When AED mode is selected, AED analysis is automatically started.





4. AED button 2nd or later Analysis

After each discharge or sequence, select whether to manually or

automatically start AED analysis.

Each Shock: Press the CHARGE/AED button to start AED analysis after

each discharge.

Each Seq: Press the CHARGE/AED button to start AED analysis after

each sequence.

OFF: AED analysis is automatically started after each discharge or

after each sequence.

5. Discharge/AED sequence

Select the number of discharges for one sequence in AED mode.

Selection list: 1, 2, 3, 4

6. CPR time (s)

Select the wait time until starting AED analysis in background after one

sequence.

Selection list: 30, 60, 90, 120, 150, 180, 210 seconds, OFF

7. CPR timing sound

Select the duration of the CPR timing sound in AED mode.

Selection list: 60, 70, 80, 90, 100, 110, 120 seconds, OFF

8. Pause time

Select the pause time to temporarily pause background AED analysis in AED

mode. In AED mode, the Multi-function key changes to the Pause function

key.

Selection list: 30, 60, 120, 180 seconds and OFF

9. Manual deb conrmation

Select the conrmation method to enter manual debrillation mode from

AED mode.

None: When the Energy/Mode Select control is set to an energy value

position, the debrillator enters manual debrillation mode. This

is useful when the operators are physicians.

Conrm: When the Energy/Mode Select control is set to an energy value

position, the conrmation key appears.

Press the OK key to enter manual debrillation mode.

This is useful when the operators are not physicians.

Password: When the Energy/Mode Select control is set to an energy

value position, the password key appears. Enter the four digit

password to enter manual debrillation mode. This is useful

when you want to specify the operator.

10. Password

Set the password to enter manual debrillation mode from AED mode.

This password is necessary when “Manual deb conrmation” is set to

“Password”. Make the four digit password using the 1, 2, 3 and 4 keys

(default setting: 1111).





3

11. Charge holding time (s)

Duration to hold energy after charging is complete.

Selection list: 30, 40, 50, 60, seconds

12. Sync mode after CV

Select operation mode after synchronized cardioversion. You can continue

synchronized cardioversion mode or return to debrillation mode.

Deb: After synchronized cardioversion, the debrillator automatically

switches to debrillation mode. After one external discharge

with the SYNC button pressed, the debrillator switches to

asynchronous debrillation mode.

Sync: After synchronized cardioversion, the debrillator remains in

synchronized cardioversion mode. Synchronized cardioversion

mode lasts until the SYNC button is pressed again.

13. Check Pulse Pattern

Select when to check the pulse.

1: After discharge, after no shockable rhythm and after CPR

2: Only after CPR

3: Pulse check not performed

4: Pulse check not performed. VF/VT detection is off during CPR.

14. ID

Set a ve digit ID number. The ID number is printed on the recording paper.

To select the digit to change, press the Item ↓ or Item ↑ key.

To select a number or letter, press the Select key. The numbers and letters

change in the following order:

“0”, “1” ... “9”, “a”, “b” ... “z”, “-”, “:”, “.”, “(space)”

When the debrillator is shipped from the factory, the ID number is set to the

serial number.

15. Power on lead

Select the lead when the debrillator power is turned on.

PADDLE: Displays ECG waveform from external paddles, internal

paddles or disposable pads.

II: Displays ECG waveform in II lead from ECG disposable

electrodes.

16. ECG leads

Select available ECG leads.

3 LEAD: I, II and III leads are available.

5 LEAD: I, II, III, aVR, aVL, aVF, V leads are available.

17. ECG, SpO2 sweep speed (mm/s)*

Select the ECG, SpO2 waveform sweep speed on the screen.

Selection list: 25, 50 mm/s (Normally select 25 mm/s.)

* The optional QI-552V DSI

interface unit or QI-553V DSI/

AUXOUT interface unit isnecessary for SpO2 or CO2

measurement.





18. CO2 sweep speed (mm/s)*

Select the CO2 waveform sweep speed on the screen.

Selection list: 6.25, 12.5 mm/s (Normally select 12.5 mm/s.)

19. Alarm Setting

Select the alarm settings when the power is turned on.

Latest: Use the alarm settings from the previous use. This is useful where

you usually use settings other than the default settings, for

example, in a pediatric department.

Default: Alarm settings are set to the default settings. This is useful when

one debrillator is used for many patients.

20. Alarm sound

Select the vital alarm sound type.

Cont tone: The alarm sounds continuously.

Beeping: The alarm sounds for 3 seconds every 30 seconds.

21. Alarm Volume

Select the alarm sound volume.


22. Charge Sound Volume

Select the charge sound volume.


23. Voice Prompt Volume

Select the voice prompt volume.

Selection list: 1, 2, 3, 4, OFF

24. Delayed recording

Select whether or not to perform delayed recording.

ON: Records the waveform 4 seconds before the Record key is pressed.

OFF: Records the same waveform as that displayed on the screen.

25. Alarm recording

Selects whether or not to perform automatic recording on vital upper/lower

alarm occurrence.

Selection list: ON, OFF

26. Record on charging after discharge

Selects whether or not to perform automatic recording when energy charging

starts.

ON (6 s), ON (12 s): Automatic recording starts when energy charging starts.

The recording stops 6 or 12 seconds after external

discharge. After the energy is fully charged and the

charge holding time is exceeded, recording stops.

OFF: Automatic recording does not start when energy

charging starts.



AUX out interface is necessary for

CO2 measurement.





3

27. Record CAL wave

Selects whether or not to record a CAL waveform at the beginning of

recording.


28. Paper speed (mm/s)

Select the paper speed of the recorder.

25: Paper feeds 25 mm per second. Usually this setting is selected.

50: Paper feeds 50 mm per second. Suitable for a patient with rapid heart

rate.

29. Periodic recording interval (min)

Select the interval of periodic recording. This setting is available when

“Periodic Rec” on the Recorder Setup screen is set to “FREE”.

Selection list: 1 to 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120 minutes

30. Printing character size

Select the character size printed on the recording paper.

Large: Prints large size characters.

Small: Prints small size characters.

31. Date format

Select the date format printed on the recording paper.

YYYY/MM/DD: year (four digits) / month (two digits) / day (two digits)

MMM/DD/YYYY: month (three digits) / day (two digits) / year (four digits)

YYYY/MMM/DD: year (four digits) / month (three digits) / day (two digits)

DD/MM/YYYY: day (two digits) / month (two digits) / year (four digits)

32. Medication

Select whether or not to display the medication function keys (Adrenalin,

Atropine, Lidocaine, Other) when the Event key is pressed.


33. AC line frequency

Selects the AC line frequency. This setting is important to reduce artifact in

SpO2 measurement.

Settings: 50, 60 Hz

34. TEST lead

Select whether or not TEST lead can be selected.

ON: TEST lead can be selected. (displayed)

OFF: TEST lead cannot be selected. (not displayed)

35. Pressure units*

Select units used in CO2 measurement.

Selection list: mmHg, kPa



AUX out interface is necessary forCO2 measurement.





36. Pacing Current Steps (TEC-5531 only)

Select the step to increase or decrease the pacing current with the PACING

OUTPUT Up/Down key.

Selection list: 1, 2, 5, 10 mA

37. Pacing Power on Settings (TEC-5531 only)

Select the pacing settings (pacing current and pacing rate) when the power is

turned on.

Default: Pacing settings are set to the default settings.

Latest: Pacing settings are set to the settings of the previous use.

39. Load Settings

Select “OK” to load the system setup settings and setup settings from the SD

card.

Selection list: OK, OFF

40. Save Settings

Select “OK” to save the system setup settings and setup settings in the SD

card.


41. Format Card

Select “OK” to format the SD card.


42. System initialize

Select “OK” to initialize the system setup settings and setup settings.


Battery Test

Refer to “Periodical Checks - Battery Test” in Section 10.

HV Capacitor Test

Refer to “Periodical Checks - HV Capacitor Test” in Section 10.

Recorder Test

Refer to “Periodical Checks - Recorder Test” in Section 10.





3

System Information

This item displays the system information.

1. On the System Setup - Menu screen, select “System Information” by

pressing the Item key and press the OK key. The system information is


2. Press the Menu key to return to the System Setup - Menu screen.

Report History

Information for maintenance is printed.

1. On the System Setup - Menu screen, select “Report History” with the Item

key and press OK. The Report History screen opens.

2. To print an error history (error code)

i) Select “Instrument report” with the Item key

ii) Press the Record key. The history of the error (error code), battery test

and HV capacitor test is recorded together. For the error code, refer to

the service manual.

To print the operation history from the selected date

i) Select “Year” with the Item key and select a year with the ↓ or ↑ key.

ii) Select the “Month”, “Day”, “Hour”, and “Minute” in the same way.

iii) Press the Record key.

To cancel printing, press the Record key.

To return to the System Setup - Menu screen, press the Menu key.

Use Voice File

In the System Setup - Use Voice File screen, you can play back the recorded

sound and ECG waveforms saved in the SD card.

1. On the System Setup - Menu screen, select “Use Voice File” by pressing the

Item key and press the OK key. The Use Voice File screen is displayed.





2. Select the le with the ↓ or ↑ key and press the Playback key. The ECG

waveforms in the selected le are played back.

• To scroll the ECG waveforms, press the ← or → key.

• To play back the sound, press the Playback key.

During playing back

• To rewind the waveforms and sound, press the ← key.

• To stop playing back, press the Stop key.

3. Press the Return key to return to the le selection list.






3

Setup Screen

NOTE

• The changed settings are immediately applied to operation when they

are selected. If you want to return a setting to its previous value, set thesetting again.

• When the screen changes to any setup screen during recording,

recording automatically stops. Record again after exiting the setup

screen.

Setup Item List

Item Description

Paddle Setup

Sync by paddle lead Select whether or not to enable synchronized cardioversion with the

PADDLE lead.

Heart rate alarm with paddle

lead

Select whether or not to generate heart rate alarms when monitoring ECG

with the PADDLE lead.

ECG Setup

AC hum lter When set to “ON”, the hum lter automatically reduces AC interference

from the ECG.

Time Constant Select the time constant for ECG display in monitoring mode.

Pacing Pulse Reject When set to “ON”, it allows correct heart rate counting when the patient

has an implanted pacemaker.

HR alarm Select the upper and lower limit of the heart rate alarm.

SpO2 Setup

Sens Select the pulse wave sensitivity.

SpO2 Sound When set to ON, the pitch of the sync sound changes according to SpO2

value.PR alarm Select the upper and lower limit of the pulse rate alarm.

SpO2 alarm Select the upper and lower limit of the SpO2 alarm.

CO2 Setup

Scale Select the scale of the CO2 waveform.

etCO2 alarm Select the upper and lower limit of the ETCO2 alarm.

RR alarm Select the upper and lower limit of the respiration rate alarm.

APNEA alarm Select the upper limit of the APNEA alarm.

Report Setup

Report Select the type of report recording.

Trend Time Select the time length to be recorded in the Trend report recording.

List Interval Select the measurement interval for Periodic List report recording.

Delete Report? Select Yes to delete all report data saved in the instrument. When Yes is

selected, further conrmation keys appear. Press the key for “Delete” to

delete all report data.

Recorder Setup

PeriodicRec Select the recording interval for the automatic periodic recording.

RecWave Select the parameter(s) which is recorded in waveform recording, alarm

report recording, event recording and automatic recording.

Date/Screen

Year, Month, Day, Hour,

Minute

Select the date and time.

2nd Wave Select the second waveform displayed on the trace 2.

QRS Setup

QRS Volume Select the QRS sync sound volume.

QRS Sound Select the source of the QRS sync sound.

VF/VT Alarm Select whether or not to detect VF/VT.

Alarm SetupHR, PR, SpO2, etCO2, RR,APNEA

Select upper/lower limits for each parameter.(Only upper limit for APNEA)





3

Report Setup

Refer to “Changing Report and Recorder Settings” in Section 8.

Recorder Setup

Refer to “Changing Report and Recorder Settings” in Section 8.

Date/Screen

On the Date/Screen screen, you can set the date and time and the waveform in

second trace.

Date and Time

Set the debrillator date and time.

NOTE

After performing the basic checks, make sure that the date and time

printed on the recording paper is correct. The date and time on the

recording paper are important parts of the medical record.

Setting range

Year: 1980 to 2079, Month: 1 to 12, Day: 1 to 31, Hour: 0 to 23, Minute: 0 to 59

1. On the Date/Screen screen, select “Year”, “Month”, “Day”, “Hour”, or

“Minute” with the Item key.

2. Set the date and/or time with the ↓ or ↑ key.

3. Repeat steps 1 and 2 to set all items.

4. Press the Menu key to return to the Setup - Menu screen.

You cannot set seconds on this screen. For the most accurate time setting,

look at your local clock. Change the minute on the debrillator and exit

the Date/Screen screen when the minute changes on your local clock. The

second count is set to 0 when you exit the Date/Screen screen after changing

the minute.





2nd Wave

Set the waveform in the second trace.

Setting TraceAcquired Parameters

ECG ECG and SpO2 ECG and CO2 ECG, SpO2 and CO2

OFF First trace ECG ECG ECG ECG

Second trace — — — —

Bar graph None SpO2 CO2 SpO2 and CO2

Cascade First trace ECG ECG ECG ECG

Second trace Cascaded ECG Cascaded ECG Cascaded ECG Cascaded ECG

Bar graph None SpO2 CO2 SpO2 and CO2

SpO2 First trace ECG ECG ECG ECG

Second trace — SpO2 — SpO2

Bar graph None — CO2 CO2

CO2 First trace ECG ECG ECG ECG

Second trace — — CO2 CO2

Bar graph None SpO2 — SpO2

SpO2/CO2* First trace ECG ECG ECG ECGSecond trace — SpO2 CO2 SpO2

Bar graph None — — CO2

SpO2/CO2* First trace ECG ECG ECG ECG

Second trace — SpO2 CO2 CO2

Bar graph None — — SpO2

* When either the SpO2 probe or CO2 sensor is connected, the waveform of the

connected parameter is displayed in the 2nd wave position. When both the

SpO2 probe and CO2 sensor are connected at the same time, the waveform of

the underlined parameter is displayed in the 2nd wave position and the other

parameter is displayed as a bar graph at the bottom of the screen.

1. On the Date/Screen screen, select “2nd Wave” with the Item key.

2. Select the waveform displayed in the second trace with the ↓ or ↑ key.


QRS Setup

Refer to “Changing ECG Settings” in Section 6-2 and “Changing SpO2 Settings”

in Section 6-3.

Alarm Setup

Refer to “Setting Alarms” in Section 7.





3

Save Report

The data of Alarm report recording, Debrillation report recording, VF Analysis

report recording and Event report recording are saved in memory. These data

can be saved in a memory card (SD card). The waveform and its information are

saved.

1. On the Setup - Menu screen, select “Save Report” and press the SET key.

The Save Report screen appears.

The list of saved report data is displayed with the latest one at the top. The

selected report data is highlighted. The data includes date and time and

report type. Up to ve report data are listed on one screen.

The “Insert SD CARD” message appears when a memory card is notinserted into the card slot. When a memory card is already inserted into the

card slot, the “Wait, searching for data” message and the remaining free

memory are displayed.

2. Insert the memory card into the card slot.

The remaining free memory of the card is displayed on the screen. While the

debrillator is checking the card, the “Wait, searching for data” message is

displayed.

When a report data on the screen has already been saved in the insertedmemory card, the le name* of the report data appears beside the data.

* Automatically assigned le number when saving a report le in an SD

card.

• To select a report data you want to save, use the ↓ or ↑ key. When there

is more data than currently displayed on the screen, “” and “” marks

appear above and below the list.

• To print the selected (highlighted) report data, press the Record key.

• To display the preview waveform of a selected report data, press the Event

key.

• To scroll the waveform, press the ← or → key.

• To close the preview screen, press the Event key.





Preview screen

3. Press the Save key. The highlighted data on the Save Report screen is saved

in the card and the automatically assigned number (“le name”) is displayed.

When the preview screen is displayed, the data of the displayed waveform is

saved. During saving, the “Saving don’t power off” message is displayed.

To return to the Setup - Menu screen, press the Menu key.

NOTE

• Data which has already been saved in the inserted card cannot be

saved in the same card.

• When the memory card is full, the “Not enough free memory”

message appears. In this case, insert another memory card.




4

4-1

4-2

4-3

4-4

Section 4 Defbrillation, SynchronizedCardioversion and AED

Section 4-1 General ........................................................................................................................................4-1.1

Section 4-2 Defibrillation.................................................................................................................................4-2.1

Section 4-3 Synchronized Cardioversion........................................................................................................4-3.1

Section 4-4 AED .............................................................................................................................................4-4.1



Operator’s Manual TEC-5500 4-1.1

4

4-1

About Defibrillation, Synchronized Cardioversion and AED .............................................................................4-1.2

Skin-Paddle Contact Impedance ......................................................................................................................4-1.3

Using the Pediatric Electrode Plate ..................................................................................................................4-1.4

Changing Paddle Settings ................................................................................................................................4-1.5

Turning Synchronized Cardioversion with PADDLE Lead On or Off.......................................................4-1.5

Turning Heart Rate Alarm with PADDLE Lead On or Off .......................................................................4-1.6

Using the ECG Waveforms from Another Monitor, Paddles or Disposable Pads for Synchronized

Cardioversion ...................................................................................................................................................4-1.7

ECG Input from Another Monitor ............................................................................................................4-1.7

ECG Input from External Paddles, Internal Paddles and Disposable Pads ............................................4-1.9

Section 4-1 General



4-1.2 Operator’s Manual TEC-5500

4. DEFIBRILLATION, SYNCHRONIZED CARDIOVERSION AND AED

About Defibrillation, Synchronized Cardioversion and AED

This section explains the procedures to perform debrillation, synchronized

cardioversion and AED. You can use external paddles, internal paddles and

disposable pads for debrillation and synchronized cardioversion. You can use

only disposable pads for AED.

WARNING

The defibrillator generates high voltage. The defibrillator must only

be operated by trained and qualified medical personnel.

NOTE

Even if a defibrillation or cardioversion is performed on a patient

appropriately, the patient may get skin burn.

• Debrillation

Used for terminating fatal arrhythmias, such as ventricular brillation and

pulseless ventricular tachycardia. Energy is discharged asynchronously.

• Synchronized cardioversion

Used for eliminating atrial brillation and atrial utter. The debrillator detects

the patient’s ECG and energy is discharged at an appropriate timing.

• AED

The debrillator analyzes the patient’s ECG. When the debrillator detects

a shockable rhythm, it automatically starts charging the selected energy.

Discharging is not performed automatically.



4


4-1. GENERAL

4-1

Skin-Paddle Contact Impedance

To perform effective debrillation or cardioversion, it is important to make

the skin-paddle contact impedance as low as possible. Recommended applied

pressure on a paddle is about 100 N (10 kg, 22 lb.) per paddle.

For this debrillator, the CONTACT lamp on the STERNUM paddle indicates

skin-paddle contact impedance.

0 to 100 Ω: Green lamp lights

100 to 200 Ω: Yellow lamp lights

More than 200 Ω: Orange lamp lights

Place the paddles so that the green lamp lights. If the green lamp does not light,

do the following.

• Apply the contact gel on the paddles uniformly.

• Shave hair on the skin where paddles are placed.

• Press the paddles against the patient and gradually increase the pressure until

the green lamp lights.

For a patient with chest hair, old patient with skin cornication (hardening) or

thin patient, the green lamp might not light. For these patients, you can discharge

energy when the lamp is yellow or orange.

In Case of Poor Contact

WARNING

If the yellow or orange lamp lights, the defibrillator may cause

serious electric burn on the patient’s skin and poor energy discharge

to the patient. In case of an emergency, medical personnel should

decide whether to execute discharge immediately, regardless of the

CONTACT lamp display, or take action to make good contact before

discharge.





Using the Pediatric Electrode Plate

The pediatric electrode plate is underneath the adult electrode plate of the

external paddle. You can also attach the optional pediatric electrode assy 44 mm

dia. on the pediatric electrode plate of the external paddle.

WARNING

Pay careful attention to the selected energy when using the pediatric

electrode plates. Applying high energy with the pediatric electrode

plates can cause skin burn because the electrode plates are small.

The current density on the pediatric electrode plates is higher than the current

density on the adult electrode plates because the pediatric electrode plates

are smaller* than the adult electrode plates. This increases the possibility of

electrical burn on the electrode plate placement area. The minimum effective

energy should be set.

* The pediatric electrode plates underneath the adult electrode plates are about

1/3 the surface area of the adult electrode plates. The pediatric electrodes assy

44 mm dia. are about 1/5 the surface area of the adult electrode plates.

To remove the adult electrode plate:

1. Turn the Energy/Mode select control to the OFF position.

NOTE

While the “Shutdown NOW” message is displayed on the screen, do

not disconnect the power cord from the defibrillator or AC outlet and

do not remove the battery pack from the defibrillator. Otherwise, the

internal data may be damaged.

2. Press the tab of the adult electrode plate to unlock the adult electrode plate.

3. Slide the adult electrode plate forward and off.



4


4-1. GENERAL

4-1

Changing Paddle Settings

Turning Synchronized Cardioversion with PADDLE Lead On or Off

Select whether or not to allow synchronized cardioversion with the PADDLE

lead.

ON: Synchronized cardioversion with PADDLE lead is available.

OFF: Synchronized cardioversion with PADDLE lead is not available (Default

setting).

WARNING

Use the ECG monitoring electrodes (disposable electrodes) to

monitor the ECG waveforms. Stable ECG cannot be acquired with

the PADDLE lead because it is difficult to hold the paddles stable.

ECG acquired from external paddles, internal paddles or disposablepads is unstable after discharge because of high polarization

voltage.

WARNING

Do not perform synchronized cardioversion with the PADDLE lead

unless it is absolutely necessary. In synchronized cardioversion

with the PADDLE lead, noise may be misrecognized as QRS and

discharge might not synchronize with the patient’s QRS.

NOTE

Firmly connect the disposable pads to the pad adapter until the connector

of the disposable pads clicks. If the pads are not attached firmly or the

pads are not connected to the pad adapter, noise appears on the ECG

waveform.

1. On the Paddle Setup screen, select “Sync by paddle lead” with the Item key.

VF/VT :

In the System Setup screen,

the VF/VT detection function

is automatically turned off.

2. Select “ON” or “OFF” with the ↓ or ↑ key.





Turning Heart Rate Alarm with PADDLE Lead On or Off

Select whether or not to generate heart rate alarms when monitoring ECG with

the PADDLE lead.

ON: Heart rate alarms are generated when monitoring ECG with the PADDLE

lead. For long term monitoring using disposable pads, set this to ON.

OFF: Heart rate alarms are not generated when monitoring ECG with the

PADDLE lead. When you use external paddles or internal paddles, set this

to OFF (default setting).

1. On the Paddle Setup screen, select “Heart rate alarm with paddle lead” with

the Item key.

2. Select ON or OFF with the ↓ or ↑ key.



4


4-1. GENERAL

4-1

Using the ECG Waveforms from Another Monitor, Paddles or

Disposable Pads for Synchronized Cardioversion

You can acquire ECG waveforms for synchronized cardioversion by thefollowing three ways.

• From the ECG connection cable and ECG disposable electrode

Refer to “Preparing for ECG Monitoring” in Section 6-2.

• From another monitor

Refer to “ECG Input from Another Monitor” in this section.

• From external paddles, internal paddles or disposable pads

Refer to “ECG Input from External Paddles, Internal Paddles and Disposable

Pads” in this section.

Whenever possible, use ECG electrode to acquire the ECG waveforms.

ECG Input from Another Monitor

When the patient is connected to a monitor, the debrillator can perform

synchronized cardioversion using the ECG signal from the monitor.

WARNING

If you use the ECG signal from the monitor, before cardioversion,check that the defibrillator discharge occurs within 60 ms of the peak

of the ECG’s R wave with an energy checker. If this condition is not

met, the cardioversion may be ineffective or may cause ventricular

fibrillation.

CAUTION

The defibrillator should only be connected to external equipment

which complies with the CISPR 11 Second Edition 1990-09, Group 1

and Class B standard.

NOTE

When receiving the ECG signal from a bedside monitor, select lead II or I

on the bedside monitor.

To use ECG signal from another monitor as the synchronizing signal of

synchronized cardioversion,

• Connect the debrillator to the other instrument with the optional JC-761V

external ECG cable.

• Select “AUX” for ECG lead.





Use the following procedure to check whether or not synchronized cardioversion

can be performed with the ECG signal from another instrument.

1. Connect the debrillator to the other instrument with the optional JC-761V

external ECG cable.

2. Turn the power of the other instrument on.

3. Turn the Energy/Mode Select control to the DISARM position.

4. Select “AUX” with the ECG lead key.

5. Connect an enegy checker to the other instrument and turn the energy

checker on to generate ECG signals.

6. Turn the Energy/Mode Select control to 50 J.

7. Press the SYNC button on the front panel.

8. Check that the “ ” mark appears on the rising slope of every QRS wave.

9. Leaving the paddles on the holders of the energy checker, press the

CHARGE button on the APEX paddle to start charging. During charging,

there is a beeping sound, a “CHARGING” message appears, and the

CHARGE lamp on the APEX paddle blinks.

When charging is completed, there is a continuous buzzing sound, the

“CHARGED” message appears, and the CHARGE lamp lights.

Red

Black

JC-761V external ECG cable

Connects to output signal line.

Connects to GND line.

10. Simultaneously press and hold both DISCHARGE buttons on the external

paddles.

11. Conrm that the debrillator discharge occurs within 60 ms of the peak of

the ECG’s R wave with an energy checker.

12. Turn the debrillator off.



4


4-1. GENERAL

4-1

ECG Input from External Paddles, Internal Paddles and Disposable Pads

The debrillator can perform synchronized cardioversion with the PADDLE

lead.

To use ECG from external paddles, internal paddles or disposable pads for

synchronizing signal of synchronized cardioversion,

• Set the “Sync by paddle lead” on the Paddle Setup screen to ON.

• Select “PADDLE” for ECG lead.

WARNING

Do not perform synchronized cardioversion with the PADDLE lead

unless it is absolutely necessary. In synchronized cardioversion

with the PADDLE lead, noise may be misrecognized as QRS and

discharge might not synchronize with the patient’s QRS.

NOTE

• Place the paddles on the patient so that the whole waveform is

displayed on the screen and the T waveform is not much higher than

the QRS waveform. Otherwise, QRS cannot be recognized correctly.

• If the defibrillator miscounts the narrow width QRS, set “Pacing Pulse

Reject” to OFF on the ECG Setup screen and confirm that QRS is

correctly recognized.




4

4-2

Section 4-2 Defbrillation

Defibrillation Screen .........................................................................................................................................4-2.2

Defibrillation with External Paddles ..................................................................................................................4-2.3

Important Safety Information ..................................................................................................................4-2.3

Procedure ...............................................................................................................................................4-2.4

Defibrillation with Disposable Pads...................................................................................................................4-2.9


Procedure .............................................................................................................................................4-2.11

Defibrillation with Internal Paddles .................................................................................................................4-2.16

Important Safety Information ................................................................................................................4-2.16

Procedure .............................................................................................................................................4-2.17





Defibrillation Screen

Screen Example

ECG lead

Sensitivity

ECG

QRS sync mark AC power operation

Number of discharges

Charged energy

Heart rate

Highlighted when it

exceeds the upper or

lower alarm limit.



4


4-2. DEFIBRILLATION

4-2

Defibrillation with External Paddles


WARNINGBefore defibrillation, all persons must keep clear

of the bed and must not touch the patient or any

equipment or cable connected to the patient.

Failure to follow this warning may cause electrical

shock or injury.

WARNINGBefore defibrillation, remove from the patient

all electrodes, probes and transducers from

connectors that do not have a or mark.


shock and the connected instrument may be

damaged.

WARNING

Before defibrillation, remove everything includingelectrodes and patches from the patient’s chest. If

the defibrillator paddle contacts an object on the

patient’s chest, the discharged energy may be

insufficient and cause skin burn.

WARNING

Before defibrillation, check that the cords andcables of the electrodes, probes and transducers

attached to the patient are properly connected to

a connector that has a or mark. Touching

the metal parts of the disconnected cords and

cables may cause electrical shock or injury by

discharged energy.

WARNING









defibrillator.

WARNING








voltage.

WARNINGDo not perform defibrillation or cardioversion in a




WARNINGThe defibrillator generates high voltage. The



NOTE

• Select the appropriate energy and appropriate size of the external

paddles according to the patient. Only use the paddles specified by

Nihon Kohden.

• Defibrillation is not available when any setup screen or system setup

screen is displayed. Before using the defibrillator, confirm and set

the necessary settings on the Setup screen and System Setup –

Configuration screen.





Procedure

1. Check that the external paddles are connected to the debrillator.

2. Turn the Energy/Mode Select control to the DISARM position to turn the

power on. Conrm that there is no error message on the screen. For error

messages, refer to “Messages” in Section 9. When operating with AC power,

conrm that the AC lamp is on.

3. Conrm that the ECG lead is set to PADDLE. If another lead is selected,

select PADDLE with the ECG lead key.

4. Conrm that the SYNC lamp is not lit. If this lamp is lit, press the SYNC

button on the front panel to turn it off.

5. Prepare the paddles.

i) Remove the external paddles from paddle holders by grasping the

handles and lifting straight up.

ii) Apply contact gel to the electrode plate surface of each paddle.

iii) Gently rub the electrode plate surfaces together to evenly spread the gel.

WARNINGApply contact gel only to the electrode plates of



WARNINGDo not apply contact gel by hand. Failure to follow



WARNING




WARNING




paddles.

6. Select the energy level.

Turn the Energy/Mode Select control to the desired energy position.



4


4-2. DEFIBRILLATION

4-2

7. Place the paddles on the patient.

WARNING

Do not touch the electrode plate or edge of the paddle. Failure to

follow this warning may cause serious electrical burn, shock, or other

injury.

CAUTION

If the patient’s body is wet, thoroughly wipe the moisture off the

skin so that the paddles do not short to each other. Otherwise, the

discharged energy may be insufficient.

Position

i) Place the left (STERNUM) paddle on the right side of sternum and

below the clavicle.

ii) Place the right (APEX) paddle on the level of fth intercostal space and

midaxillary line. When using the paddle lead, keep the paddles steady.

NOTE

Do not lean against the paddles when pressing them on the

patient. A paddle may slip and cause injury.

STERNUM

APEX

8. Check the ECG waveform.

Conrm that the patient’s ECG has a shockable rhythm, such as ventricular

brillation or pulseless ventricular tachycardia.

If the patient’s ECG requires synchronized cardioversion, follow the

procedure in Section 4-3 “Synchronized Cardioversion”.





9. Charge the energy.

When it is veried that the patient needs debrillation, press the CHARGE

button on the APEX paddle or CHARGE/AED button on the front panel to

start charging.

WARNINGWhen charging or discharging, do not touch anything other than

the handles. If any other part of the defibrillator is touched during

charging or discharging, the operator receives an electrical shock.

WARNING

Do not move the defibrillator when any charged energy remains in

the defibrillator. If the defibrillator receives any impact, such as from

falling, it discharges energy that can cause electrical shock.

During charging, there is a beeping sound, the “CHARGING” message

appears on the screen, and the CHARGE lamp blinks.


“CHARGED” message appears on the screen, and the CHARGE lamplights.

To change the energy level after charging is completed

Turn the Energy/Mode Select control to the desired energy position. The

debrillator starts adjusting the energy one second after the new energy is

selected.

When debrillation becomes unnecessary after charging is completed

Turn the Energy/Mode Select control to the DISARM position or OFF

position. The debrillator internally discharges charged energy within 20

seconds.

The debrillator automatically internally discharges charged energy when

the charge holding time passes. This time is selected on the System Setup -

Conguration screen.

Bad example



4


4-2. DEFIBRILLATION

4-2

Defibrillation with Disposable Pads


WARNINGBefore defibrillation, all persons must keep clear




shock or injury.

WARNINGBefore defibrillation, remove from the patient





damaged.

WARNING

Before defibrillation, remove everything including

electrodes and patches from the patient’s chest.

If the disposable pad contacts an object on the



WARNING

Before defibrillation, check that the cords and

cables of the electrodes, probes and transducers





discharged energy.

WARNING









defibrillator.

WARNING








voltage.




WARNINGDo not perform defibrillation or cardioversion in a




WARNING








WARNING





• If the pad package is torn, dispose of the padsand do not use them.











protective sheet.

CAUTION




insufficient pacing current and insufficient energy


CAUTION



CAUTION




patient.

NOTE

• Follow all disposable pad labeling instructions.

• Always have spare disposable pads. Use the spare pads if the gel of

the original pads is dry, deteriorated or discolored.

• Before attaching the disposable pads to the patient, clean the skin

where the pads will be attached. If the skin is moist, wipe the skin.

• Only use the pads specified by Nihon Kohden.

• Defibrillation is not available when any Setup screen or System

Setup screen is displayed. Before using the defibrillator, confirm and

set the necessary settings on the Setup screen and System Setup -




4


4-2. DEFIBRILLATION

4-2

Procedure

1. Connect the pad adapter to the debrillator.

i) Press the paddle release knob of the paddle connector on the front panel

and remove the external paddles from the paddle connector.

Paddle release knob

ii) Connect the pad adapter to the paddle connector until it clicks.

CAUTION

Do not bend or damage the connector pins of the pad adapter and

paddle connector. Energy cannot be fully discharged if pins are bentor damaged.





3. Conrm that the ECG lead is set to PADDLE. If another lead is selected,select PADDLE with the ECG lead key.



5. Prepare the disposable pads.

i) For good pad-skin contact, clean the patient’s chest to remove oil and

dirt, and thoroughly dry the skin. Shave excessive hair if necessary.

NOTE

Do not apply any gel or paste when using disposable pads.





ii) Take the disposable pads out of the package and carefully remove the

protective liner from one pad at a time.

iii) Attach the pads to the patient’s body, one at a time.

WARNING

• Do not attach pads on the papilla, electrodes or medicine on the

patient’s body. Failure to follow this warning causes serious skin

burn.

• Fit the pad closely to the body surface so that current flows

uniformly through the pad. Failure to follow this warning causes

serious skin burn or insufficient energy discharge to the heart.

CAUTION

If the patient s body is wet, thoroughly wipe the moisture off the

skin so that the pads do not short to each other. Otherwise, the


NOTE

When the skin-pad contact is poor, it causes high electrode impedance

and energy cannot be charged.

Apex-Anterior placement

RA: Right side of sternum and below the clavicle

LL: On the level of fifth intercostal space and midaxillary line



4


4-2. DEFIBRILLATION

4-2

Apex-Posterior placement

RA: Between right scapula and spine


iv) Connect the disposable pads to the pad adapter.

NOTE

• Firmly connect the disposable pads to the pad adapter until the

connector of the disposable pads clicks.

• When the “Change disposable pads” message appears,

the pads may be faulty. Replace them with new ones. If the

message still appears after replacing the pads, stop using the

defibrillator and use a different defibrillator.


Conrm that the patient’s ECG has a shockable rhythm, such as ventricularbrillation or pulseless ventricular tachycardia.






When it is veried that the patient needs debrillation, press the CHARGE/AED button on the front panel to start charging.





WARNING

During charging or discharging, do not touch the pads or connectors.

Failure to follow this warning causes electrical shock to the operator.

WARNINGDo not move the defibrillator when any charged energy remains in



NOTE

• If the CHARGE/AED button is pressed when a disposable pad is

detached from the patient, charging does not start.

• If a disposable pad is detached during or after charging, the

defibrillator automatically discharges energy internally within 20

seconds.

During charging, there is a beeping sound and the “CHARGING” message

appears on the screen.


“CHARGED” message appears on the screen, and the DISCHARGE lamp

blinks.




selected.




seconds.


the charge holding time has passed. This time is selected on the System

Setup - Conguration screen.



4


4-2. DEFIBRILLATION

4-2

9. Discharge the energy to the patient.

After conrming that the DISCHARGE lamp blinks, press the DISCHARGE

button on the front panel to discharge the energy to the patient.

WARNING





WARNING





WARNING

Before defibrillation, all persons must keep clear



Failure to follow this warning may cause electricalshock or injury.

10. If another debrillation is required, perform necessary medical treatment and

repeat steps 7 to 9.

11. Turn the power off.

Turn the Energy/Mode Select control to the OFF position.

NOTE





Press the paddle release knob of the paddle connector to the right and

remove the pad adapter from the paddle connector. Hold the connector part

to disconnect the pad adapter. Otherwise the connector gets damaged and the

cable breaks.

Dispose of the disposable pads. Refer to “Cleaning, Disinfecting and

Sterilization” in Section 10.





Defibrillation with Internal Paddles


By directly applying the internal paddles to the heart, debrillation during open

chest operation is available.

WARNING





shock or injury.

WARNING

Before defibrillation, remove from the patient





damaged.

WARNING


electrodes and patches from the patient’s chest. If

the defibrillator paddle contacts an object on the



WARNING







discharged energy.

WARNING









defibrillator.

WARNING








voltage.

WARNING




WARNING


to sterilize the paddles may cause serious

infection.

WARNING


using internal paddles. Applying high energy to

the heart may cause cardiac muscle necrosis.


WARNING







4


4-2. DEFIBRILLATION

4-2

CAUTION

Do not twist the internal paddle while holding the electrode or give

strong impact to the paddle. It damages the electrode.

NOTE

• Select the appropriate energy and appropriate size of the internal


Nihon Kohden.





Procedure

It is reported that the cardiac muscle may necrose if high energy is repeatedly

applied to the heart with internal paddles. Refer to “Reference” in Section 11.

1. Connect the internal paddles to the debrillator.

i) Press the paddle release knob of the paddle connector to the right and

remove the external paddles from the paddle connector.

Paddle release knob

ii) Connect the internal paddles to the paddle connector until it clicks.

CAUTION

Do not bend or damage the connector pins of the paddle connector.

Energy cannot be fully discharged if pins are bent or damaged.











4. Position the internal paddles.

Position the sterilized internal paddles against the right and the left atria of

the heart.

NOTE

• It is not necessary to consider the polarities of the internal paddle

electrodes.• For better contact between the internal paddles and heart, place

sterilized gauze moistened with physiological saline solution

between each internal paddle and the heart.


Conrm that the patient’s ECG has a shockable rhythm, such as ventricular

brillation or pulseless ventricular tachycardia.





When the internal paddles are used, 50 J or below can be selected. If above

50 J is selected, the “Set energy to 50 J or less” message appears on the

screen and the selected energy cannot be charged.


When it is veried that the patient needs debrillation, press the CHARGE/

AED button on the front panel to start charging.

Guard

Example of using the ND-590V series internal paddles



4


4-2. DEFIBRILLATION

4-2

WARNING

When charging or discharging, grip the internal paddles between the

cable and the guard at the top of the handle. If the internal paddles

are gripped between the electrode and the guard, the operator

receives an electrical shock.

WARNING








blinks.




selected.

NOTE

If above 50 J is selected, the defibrillator immediately discharges

energy internally.




seconds.









When using the ND-590V series internal paddles

Press the discharge switch on the paddle handle to discharge the energy to

the patient. Firmly hold the handles of the internal paddles until discharge

nishes.

When using the ND-760V series internal paddles

After conrming that the DISCHARGE lamp blinks, press the DISCHARGE

button on the front panel to discharge the energy to the patient. Firmly hold

the handles of the internal paddles until discharge nishes.

WARNING





shock or injury.

WARNING





WARNING





WARNING




9. If another debrillation is required, perform necessary medical treatment and

repeat steps 6 to 8.



NOTE






remove the internal paddles from the paddle connector. Hold the connector

part to disconnect the paddle connector. Otherwise the connector gets

damaged and the cable breaks.

Wash off blood from the internal paddles and sterilize them. Refer to

“Cleaning, Disinfecting and Sterilization” in Section 10.




4

4-3

Section 4-3 Synchronized Cardioversion

Synchronized Cardioversion Screen ................................................................................................................4-3.2

Synchronized Cardioversion with External Paddles .........................................................................................4-3.3


Procedure ...............................................................................................................................................4-3.4

Synchronized Cardioversion with Disposable Pads ........................................................................................ 4-3.10


Procedure .............................................................................................................................................4-3.12

Synchronized Cardioversion with Internal Paddles ........................................................................................4-3.18


Procedure .............................................................................................................................................4-3.19





Synchronized Cardioversion Screen

Screen Example

Heart rate

ECG lead

QRS sync mark Synchronization point

AC poweroperation

SYNC mode

Charged energy

ECG

Sensitivity



4


4-3. SYNCHRONIZED CARDIOVERSION

4-3

Synchronized Cardioversion with External Paddles


WARNINGBefore cardioversion, all persons must keep clear




shock or injury.

WARNINGBefore cardioversion, remove from the patient





damaged.

WARNINGBefore cardioversion, remove everything

including electrodes and patches from thepatient’s chest. If the defibrillator paddle contacts

an object on the patient’s chest, the discharged

energy may be insufficient and cause skin burn.

WARNINGBefore cardioversion, check that the cords and

cables of the electrodes, probes and transducersattached to the patient are properly connected to




discharged energy.

WARNINGWhen using an ESU, use this defibrillator


electrodes for monitoring. Do not monitor ECGwith disposable pads, external paddles or





defibrillator.

WARNING




WARNINGUse the ECG monitoring electrodes (disposable







voltage.

WARNINGDo not perform synchronized cardioversion

with the PADDLE lead unless it is absolutely

necessary. In synchronized cardioversion with the

PADDLE lead, noise may be misrecognized as

QRS and discharge might not synchronize with


WARNINGDo not perform cardioversion in a wet place.

Before cardioversion, move the patient and

defibrillator to a dry place. Otherwise the operator

may get electrical shock.








CAUTION

When performing synchronized cardioversion, confirm that the

SYNC lamp is lit before every discharge. If “Sync mode after CV”

is set to Defib on the System Setup - Configuration screen, the

defibrillator automatically turns to the asynchronous defibrillation

mode.

NOTE

• Select the appropriate energy and appropriate size of the external


Nihon Kohden.

• Cardioversion is not available when any Setup screen or System




Procedure

1. Check that the external paddles are connected to the debrillator.





3. Prepare the patient to monitor the ECG waveforms.

When monitoring ECG waveform with the ECG connection cable and

disposable electrodes,

i) Connect the ECG connection cable to the ECG input connector on the

front panel.

ii) Attach the disposable electrodes to the patient. Refer to “Preparing for

ECG Monitoring” in Section 6-2.

iii) Clip the ECG connection cable to the electrode. Conrm that electrodes

are not pulled by the ECG connection cable.

To acquire ECG waveform from another monitor, refer to “Using the

ECG Waveforms from Another Monitor, Paddles or Disposable Pads for

Synchronized Cardioversion” in Section 4-1.

4. Press the ECG lead key to select the lead which has the highest QRS wave.

When acquiring synchronizing signal with the ECG connection cable

and disposable electrodes, usually “II” is selected. When using the ECG

waveform from another monitor, select “AUX”.



4



4-3

WARNING

Never select “TEST” for the ECG lead. “TEST” is for maintenance

and the waveform displayed on the screen is not the patient’s ECG.

If synchronized cardioversion is performed with the TEST lead, the

discharge is not synchronized with the patient’s QRS and it may

cause ventricular fibrillation.

NOTE

• Select a lead so that the whole waveform is displayed on the screen

and the T waveform is not much higher than the QRS waveform.

Otherwise, QRS cannot be recognized correctly.

• If the defibrillator miscounts the narrow width QRS, set “Pacing

Pulse Reject” to OFF on the ECG Setup screen and confirm that

QRS is correctly recognized.

5. Select SYNC mode.

i) Press the SYNC button on the front panel to select the synchronized

cardioversion mode. Conrm that the SYNC lamp lights and “SYNC” is


ii) Check that the “ ” mark appears on the rising slope of every QRS wave.

The “ ” mark indicates that the debrillator detects the QRS wave. If

the mark does not appear, correct synchronization is not available. Do

the following to display the “ ” mark on the rising slope of every QRS

wave:

• Change the amplitude of the ECG waveforms with the ECG sensitivity

key.

• Change the ECG lead with the ECG lead key.

• Change the electrode position.

NOTE

• When the Energy/Mode Select control is set to MONITOR, AED,

DEMAND or FIXED position, the SYNC mode cannot be selected.

• If the Energy/Mode Select control is set to MONITOR, AED,

DEMAND or FIXED position while the SYNC mode is selected

(SYNC lamp is lit), the defibrillator exits the SYNC mode.

6. Prepare the paddles.

i) Remove the external paddles from paddle holders by grasping the

handles and lifting straight up.

ii) Apply contact gel to the electrode plate surface of each paddle.

iii) Gently rub the electrode plate surfaces together to evenly spread the gel.

WARNING

Apply contact gel only to the electrode plates of



WARNING

Do not apply contact gel by hand. Failure to follow







WARNING




WARNING




paddles.



8. Place the paddles on the patient.

WARNING

Do not touch the electrode plate or edge of the

paddle. Failure to follow this warning may causeserious electrical burn, shock, or other injury.

CAUTION


moisture off the skin so that the paddles do notshort to each other. Otherwise, the discharged


Position

i) Place the left (STERNUM) paddle on the right side of sternum and

below the clavicle.

ii) Place the right (APEX) paddle on the level of fth intercostal space and

midaxillary line. When using the paddle lead, keep the paddles steady.

NOTE

Do not lean against the paddles when pressing them on the patient. A

paddle may slip and cause injury.

STERNUM

APEX



4



4-3


When it is veried that the patient needs synchronized cardioversion, press

the CHARGE button on the APEX paddle or CHARGE/AED button on the

front panel to start charging.

WARNINGWhen charging or discharging, do not touch anything other than

the handles. If any other part of the defibrillator is touched during

charging or discharging, the operator receives an electrical shock.

WARNING








blinks.




selected.

When cardioversion becomes unnecessary after charging is completed



seconds.




Bad example





10. Check the skin-paddle contact impedance.

The skin-paddle contact impedance is indicated by the CONTACT lamp

on the STERNUM external paddle. Press the paddles against the paddle

placement area so that the green lamp lights. Refer to “Skin-Paddle Contact

Impedance” in Section 4-1.


After conrming that the DISCHARGE lamp blinks and the SYNC lamp

lights, press the DISCHARGE buttons on the paddles to discharge the

energy to the patient. Hold the buttons pressed until energy is discharged.

DISCHARGE buttons

CHARGE button





shock or injury.

WARNINGBefore discharging, confirm that the paddles are

firmly pressed against the chest wall. Failure

to follow this warning causes skin burn or poor

energy discharge to the heart.

WARNING





WARNING




WARNING

Do not discharge the energy if the paddles are

shorted to each other by contact gel. It may

cause skin burn and poor energy discharge to the

heart.

Bad example



4



4-3

12. If another cardioversion is required, perform necessary medical treatment

and repeat steps 5 and 7 to 11.

Use the edge around each paddle holders to temporarily hold the paddles so

that contact gel does not get on the debrillator. These holders can only be

used for the adult electrode plate.


Turn the Energy/Mode Select control to the OFF position to turn the

debrillator power off.

NOTE





Thoroughly wipe off the contact gel from the external paddles and

debrillator. Refer to “Cleaning, Disinfecting and Sterilization” in Section

10.

Put the external paddles to the paddle holders.





Synchronized Cardioversion with Disposable Pads






shock or injury.

WARNINGBefore cardioversion, remove from the patient





damaged.

WARNING

Before cardioversion, remove everything

including electrodes and patches from the

patient’s chest. If the disposable pad contacts



WARNING

Before cardioversion, check that the cords and






discharged energy.

WARNING









defibrillator.

WARNING








voltage.

WARNINGConfirm that there is no noise on the ECG. Noise








4



4-3

WARNING
















protective sheet.

WARNING




WARNING





CAUTION






CAUTION



CAUTION




patient.

CAUTION







NOTE






• Only use the pads specified by Nihon Kohden.

• Cardioversion is not available when any Setup screen or System Setup

screen is displayed. Previously confirm and set the necessary settings

on the Setup screen and System Setup - Configuration screen.





Procedure




Paddle release knob


CAUTION


paddle connector. Energy cannot be fully discharged if pins are bent

or damaged.






When monitoring ECG waveforms with the ECG connection cable and



front panel.

ii) Attach the disposable electrodes to the patient. Refer to “Preparing for

ECG Monitoring” in Section 6-2.



To acquire ECG waveforms from another monitor, refer to “Using the





4



4-3


When acquiring a synchronizing signal with the ECG connection cable



WARNINGNever select “TEST” for the ECG lead. “TEST” is for maintenance





NOTE















wave:


key.



NOTE













NOTE





WARNING



burn.


uniformly through the pad. Failure to follow this warning causesserious skin burn or insufficient energy discharge to the heart.

CAUTION




NOTE

When the skin-pad contact is poor, it causes high electrode impedanceand energy cannot be charged.



4



4-3








NOTE















the CHARGE/AED button on the front panel to start charging.

WARNING



WARNING




NOTE



• If a disposable pad is detached during or after charging, the

defibrillator automatically discharges energy internally within 20

seconds.





blinks.




selected.

When cardioversion becomes unnecessary after charging is completed



seconds.



4



4-3





After conrming that the DISCHARGE lamp blinks and SYNC lamp lights,

press the DISCHARGE button on the front panel to discharge the energy to

the patient. Hold the buttons pressed until energy is discharged.

WARNING

Before discharging, confirm that the pads are firmly attached to the

skin. Failure to follow this warning causes skin burn or poor energy


WARNINGDo not discharge if the pads overlap each other or are shorted to

each other by anything conductive such as contact gel. This may

cause skin burn and poor energy discharge to the heart.

WARNING

Before defibrillation, all persons must keep clear of the bed and must

not touch the patient or any equipment or cable connected to the

patient. Failure to follow this warning may cause electrical shock or

injury.

10. If another cardioversion is required, perform necessary medical treatment

and repeat steps 5 and 7 to 9.



NOTE








cable breaks.

Dispose of the disposable pads. Refer to “Cleaning, Disinfecting and






Synchronized Cardioversion with Internal Paddles


By directly applying the internal paddles to the heart, cardioversion during open

chest operation is available.

WARNING

Before cardioversion, all persons must keep clear




shock or injury.

WARNING

Before cardioversion, remove from the patient





damaged.

WARNING

Before cardioversion, remove everything

including electrodes and patches from the

patient’s chest. If the defibrillator paddle contacts



WARNING

Before cardioversion, check that the cords and






discharged energy.

WARNING









defibrillator.

WARNING








voltage.

WARNING




WARNING




WARNING


to sterilize the paddles may cause seriousinfection.

WARNING


using internal paddles. Applying high energy tothe heart may cause cardiac muscle necrosis.




4



4-3

WARNING

Do not perform cardioversion in a wet place.

Before cardioversion, move the patient and

defibrillator to a dry place. Otherwise the operator

may get electrical shock.

CAUTION

Do not twist the internal paddle while holding the

electrode or give strong impact to the paddle. It

damages the electrode.

CAUTION







NOTE• Select the appropriate energy and appropriate size of the internal


Nihon Kohden.

• Cardioversion is not available when any Setup screen or System




Synchronized cardioversion should be performed with the minimum effective

energy. It is reported that the cardiac muscle may necrose if high energy isrepeatedly applied to the heart with internal paddles. Refer to “Reference” in

Section 11.

Procedure

1. Connect the internal paddles to the debrillator.

i) Press the paddle release knob of the paddle connector to the right and

remove the external paddles from the paddle connector.

Paddle release knob





ii) Connect the internal paddles to the paddle connector until it clicks.

CAUTION

Do not bend or damage the connector pins of the paddle connector.

Energy cannot be fully discharged if pins are bent or damaged.






When monitoring ECG waveform with the ECG connection cable and



front panel.

ii) Attach the disposable electrodes to the patient. Refer to Section 6-2

“Preparing for ECG Monitoring”.



To acquire ECG waveform from another monitor, refer to “Using the




When acquiring a synchronizing signal with the ECG connection cable





4



4-3

WARNING






NOTE















wave:


key.



NOTE










6. Position the internal paddles.

Position the sterilized internal paddles against the right and the left atria of

the heart.

NOTE

• It is not necessary to consider the polarities of the internal paddle

electrodes.

• For better contact between the internal paddles and heart, place

sterilized gauze moistened with physiological saline solution

between each internal paddle and the heart.



When the internal paddles are used, 50 J or below can be selected. If above

50 J is selected, the “Set energy to 50 J or less” message appears on the

screen and the selected energy cannot be charged.



the CHARGE/AED button on the front panel to start charging.

Guard

Example of using the ND-590V series internal paddles

WARNING

When charging or discharging, grip the internal paddles between the

cable and the guard at the top of the handle. If the internal paddles

are gripped between the electrode and the guard, the operator

receives an electrical shock.

WARNING








WARNING

Before cardioversion, all persons must keep clear




shock or injury.

WARNING





WARNING





WARNING




10. If another cardioversion is required, perform necessary medical treatmentand repeat steps 5 to 9.



NOTE






remove the internal paddles from the paddle connector. Hold the connector

part to disconnect the paddle connector. Otherwise the connector gets

damaged and the cable breaks.

Wash off blood from the internal paddles and sterilize them. Refer to

“Cleaning, Disinfecting and Sterilization” in Section 10.




4

4-4

Section 4-4 AED

AED Screen ......................................................................................................................................................4-4.2

Important Safety Information ............................................................................................................................4-4.3

AED Flowchart .................................................................................................................................................4-4.5

Preparation for AED Mode .....................................................................................................................4-4.6

AED Procedure .................................................................................................................................................4-4.7

When Nonshockable Rhythm is Detected in AED Analysis .................................................................4-4.15





AED Screen

In AED mode, the debrillator analyzes the ECG waveforms (AED analysis).

When shockable waveform (ventricular brillation and ventricular tachycardia)

is detected, the debrillator automatically charges the preset energy.

1st charge energy (currently selected energy is highlighted.)

Alarm off mark 2nd charge energy

3rd charge energy

AC power operation

AED mode

Charged energy

Pause keyWhen AED mode is selected, the Multi-

function key changes to the Pause key to

temporarily stop AED analysis.

ECG

Sensitivity

Heart rate

ECG lead

Screen Example



4


4-4. AED

4-4


WARNING

Before defibrillation, all persons must keep clearof the bed and must not touch the patient or any



shock or injury.

WARNING

When using an ESU, use this defibrillatoronly in the MONITOR mode and use the ECG







defibrillator.

WARNINGUse the ECG monitoring electrodes (disposable







voltage.




WARNING




WARNING









• Use the disposable pads as soon as possibleafter opening the package.







protective sheet.





CAUTION






CAUTION



CAUTION




patient.

NOTE

• AED mode can only be used for patients who are age 8 or older, or atleast 25 kg.












4


4-4. AED

4-4

AED Flowchart

shockable rhythm

Defibrillation not necessary. Check ECG.Defibrillation necessary. Check ECG.

Press CHARGE/AED button.

Check pulse **

If no pulse, start CPR. **

nonshockable rhythm

Each shock or Each Seq.

OFF

Press CHARGE/AED button

Turn Energy/Mode Select

control to AED

VF analysis startsAnalyzing VFStand clear

Result?

End sequence?

Charging startsCHARGING

Charging finishesCHARGED

Stand clear and press DISCHARGE buttons.

If no pulse, press AED button. **

CPR timing sound generates

Press DISCHARGE button

CPR time (s)

When set to OFF

When set to any number

AED button 2nd

or later Analysis(start analysis manually?)

AED button 2nd

or later Analysis

(start analysis manually?)

AED button

First Analysis

End after selected time

ON

Yes

No

OFF

Each shock

Each Seq. or OFF

*

User operation

Instrument operation

Bold: Displayed message

Italic : Settings in System Setup screen

AED

CPR

* If debrillation becomes necessary during CPR, press the CHARGE/AED button. Analysis immediately starts and

operation proceeds from the “VF analysis starts” step in the owchart.

** “Check pulse”, “If no pulse, start CPR” and “If no pulse, press AED button” messages are not displayed when the

“Check Pulse Pattern” on the System Setup screen is set to 3 (no checking pulse).





Preparation for AED Mode

Change the following settings if necessary. Refer to “System Setup Screen” in

Section 3. The factory default settings are underlined.

AED

• AED Energy (2 to 100, 150, 200, 270 J)

The rst, second and third energy in each discharge/AED sequence. When

a shockable waveform is detected, the selected energy is automatically

charged. The number of discharges for one sequence is set in “Discharge/

AED sequence”. (Default setting: 150 J for the 1st discharge, 200 J for the 2nd

discharge and 270 J for the 3rd discharge)

• Energy after 3rd discharge (Repeat cycle, 3rd energy)

The energy after the third discharge.

• AED button First Analysis (ON, OFF)

When AED mode is selected, select whether or not to start AED analysis

(shockable waveform detection) by pressing the CHARGE/AED button. If

“ON” (default setting) is selected, you must press the CHARGE/AED button

to start AED analysis.

• AED button 2nd or later Analysis (Each shock, Each Seq., OFF)

Select whether to manually or automatically start AED analysis after each

discharge or each sequence. Select “OFF” to automatically start AED analysis.

If “Each shock” or “Each Seq.” is selected, you must press the CHARGE/AED

button to start AED analysis.

• Discharge/AED sequence (2, 3, 4)

The number of discharges for one sequence.

• Pause time (30, 60, 120, 180 seconds and OFF)

In AED mode, the Multi-function key changes to the Pause key. Background

AED analysis can be temporarily paused by pressing the PAUSE key. Select

pause time for background AED analysis.

CPR

• CPR time (s) (30, 60, 90, 120, 150, 180, 210 seconds, OFF)

The time until starting AED analysis in background after a discharge/AED

sequence.

• CPR timing sound (60, 70, 80, 90, 100, 110, 120 times/min, OFF)

Duration of CPR timing sound.



4


4-4. AED

4-4

AED Procedure

1. Conrm that the patient is unconscious and has no respiration and no pulse.

CAUTION

Before ECG analysis in AED mode or defibrillation, confirm that the

patient is unconscious and has no respiration and no pulse.

CAUTION

The ECG of a child or a patient with an implanted pacemaker cannot

be analyzed correctly. For these patients, follow the physician’s

instruction.





CAUTIONDo not bend or damage the connector pins of the pad adapter and


or damaged.

3. Turn the Energy/Mode Select control to the AED position to turn the power

on. Conrm that there is no error message on the screen. For error messages,

refer to “Messages” in Section 9. When operating with AC power, conrm

that the AC lamp is on.

When AED mode is selected, the Multi-function key changes to the Pause

key. To temporarily pause background AED analysis, press the Pause key.

The pause time is set on the System Setup - Conguration screen. When the

Pause key is pressed, it changes to the Resume key. To start AED analysis,

press the Resume key.

Paddle release knob





4. Conrm that “PADDLE” is selected for ECG lead.

NOTE

In AED mode, other ECG leads cannot be selected.


i) For good pad-skin contact, clean the patient’s chest to remove oil,

moisture and dirt, and thoroughly dry the skin. Shave excessive hair if

necessary.

NOTE








WARNING



burn.• Fit the pad closely to the body surface so that current flows

uniformly through the pad. Failure to follow this warning causes

serious skin burn or insufficient energy discharge to the heart.



4


4-4. AED

4-4

CAUTION




NOTE

When the skin-pad contact is poor, it causes high electrode

impedance and energy cannot be charged.


NOTE

• Firmly connect the disposable pads to the pad adapter until

the connector of the disposable pads clicks. If the pads are

not attached firmly or the pads are not connected to the pad

adapter, noise appears on the ECG waveform.





6. Conrm the selected energy values.

Three selected energy values are displayed on the upper screen. The 1st

energy is selected. The selected energy is highlighted. Conrm that the

energy is proper.

To change the energy values, use the “AED Energy” setting in the System

Setup - Conguration screen. Refer to Section 3.

The following waveforms are saved in memory.

• Waveform of 10 seconds before and 12 seconds after discharge

• Waveform of 6 seconds after the CHARGE/AED button is pressed

If you want to record any other waveform, press the Record key and print

the waveform on the recording paper. Waveform of 6 seconds after the

CHARGE/AED button is pressed can be printed as a report. For details, refer

to Section 8 “Recording”.





7. Start AED analysis.

Stop the life saving treatment such as CPR, keep the patient at rest and do

not touch or move the patient, pad adapter and disposable pad cable. Then

press the CHARGE/AED button on the front panel. The background AED

analysis starts and the “Stand clear” message appears on the screen.

To automatically start background AED analysis, set “AED button First

Analysis” in the System Setup - Conguration screen to “OFF”.

Selected energy

WARNING

When you perform defibrillation in an ambulance, stop the car.

CAUTION

Before and during ECG analysis in AED mode, note the following.

Otherwise, correct analysis result cannot be obtained.

• Do not touch or move the patient.

• Stop life saving treatment such as CPR.

• If the ECG baseline wanders due to conditions such as poor skin-

pad impedance or movement of the pad adapter or pad cable,

remove the causes.

NOTE

If a shockable rhythm is detected after the CHARGE/AED button is

pressed, the defibrillator automatically starts charging the selected

(highlighted) energy. Therefore, take much care for handling the

CHARGE/AED button.

Waveforms of 6 seconds after the CHARGE/AED button is pressed and

the analysis result can be recorded as VF Analysis report recording. Up

to 124 waveforms can be saved in memory. The oldest 31 waveforms are

deleted when you save over 124 waveforms. For details, refer to Section 8

“Recording”.



4


4-4. AED

4-4

8. “CHARGING” message appearance

When a shockable rhythm is detected, the “Debrillation necessary. Check

ECG” and “CHARGING” messages appear on the screen and there is a

continuous beeping sound. The debrillator automatically charges the

selected energy (highlighted energy on the screen).

WARNING



WARNING


the defibrillator. If the defibrillator receives any impact, such as fromfalling, it discharges energy that can cause electrical shock.

NOTE

• Asystole is not judged to be a shockable rhythm and the defibrillator

does not automatically charge the energy.

• If the amplitude of a waveform is very small, the waveform may not be

judged as a shockable rhythm and automatic energy charging may not

be performed.

Automatic energy charging criteria is:

- Ventricular fibrillation with average amplitude not less than 0.1 mV, or- Ventricular tachycardia with pulse rate not less than 180/min

• When small amplitude ventricular fibrillation is not judged to be

shockable rhythm, follow the physician’s instruction and continue the

appropriate treatment. By continuing CPR, the amplitude of ventricular

fibrillation may become large and reanalysis may start automatic

energy charging.

• Pay attention to the change in ECG after automatic energy charging

starts.



• If a disposable pad is detached during or after charging, the defibrillator

automatically discharges energy internally within 20 seconds.





9. “CHARGED” message appearance


“Stand clear and press DISCHARGE button” and “CHARGED” messages

appear on the screen, and the DISCHARGE lamp blinks.


To quit debrillation, turn the Energy/Mode Select control to the DISARM

position or OFF position to internally discharge the charged energy.

After charging is complete, if nonshockable rhythm is detected, the

debrillator automatically discharges the charged energy internally. For the

nonshockable rhythm, refer to “When Nonshockable Rhythm is Detected in

AED Analysis” in this section.

The time until internal discharge is set at “Charge holding time” on the

System Setup - Conguration screen.

WARNING



WARNINGDo not move the defibrillator when any charged energy remains in





4


4-4. AED

4-4


Conrm that the DISCHARGE lamp blinks. Then press the DISCHARGE

button on the front panel to discharge the energy to the patient.

WARNING





shock or injury.

WARNING

Before defibrillation, remove from the patient





damaged.

WARNING


electrodes and patches from the patient’s chest.If the disposable pad contacts an object on the



WARNING


cables of the electrodes, probes and transducersattached to the patient are properly connected to




discharged energy.

WARNING





WARNING





WARNING





WARNING




WARNING





NOTE

Firmly press the DISCHARGE button.

After debrillation, the debrillator returns to the condition of before AED

analysis starts. The selected energy switches to the next energy. The next

energy is highlighted on the upper screen.





11. Start AED analysis for the second discharge.

The debrillator automatically starts reanalysis (when “AED button 2nd or

later analysis” is set to “Each Seq.” (default setting) or “OFF” on the System

Setup - Conguration screen).

When the analysis result is shockable rhythm, the debrillator starts charging

the 2nd energy. Do steps 8 to 10 to discharge the energy to the patient.

When the analysis result is nonshockable rhythm, refer to “When

Nonshockable Rhythm is Detected in AED Analysis” in this section.

12. Start AED analysis for the third discharge.

The debrillator automatically starts reanalysis (when “AED button 2nd or

later analysis” is set to “Each Seq.” (default setting) or “OFF” on the System

Setup - Conguration screen).

When the analysis result is shockable rhythm, the debrillator starts charging

the 3rd energy. Do steps 8 to 10 to discharge the energy to the patient.

When the analysis result is nonshockable rhythm, refer to “When

Nonshockable Rhythm is Detected in AED Analysis” in this section.

13. If all the debrillations performed in the steps 6 to 12 failed, do necessary

treatments such as CPR. The CPR timing sound occurs according to the

setting value at the “CPR timing sound” on the System Setup - Conguration

screen.

During CPR, to temporarily pause background AED analysis, press the

Pause key. When the Pause key is pressed, it changes to the Resume key.

To start background AED analysis, press the Resume key. The CPR timing

sound stops.

NOTE

When defibrillation becomes necessary during CPR, press the

CHARGE/AED button to immediately start analysis.

14. If the patient needs debrillation after CPR, repeat the steps from 7. On the

System Setup - Conguration screen, you can select two types of energy

selection after the 3rd debrillation. Refer to Section 3.



NOTE







4


4-4. AED

4-4

16. Press the paddle release knob of the paddle connector to the right and



cable breaks.

17. Dispose of the disposable pads. Refer to “Cleaning, Disinfecting and


When Nonshockable Rhythm is Detected in AED Analysis

In AED analysis, nonshockable rhythm is detected in the following cases.

• Asystole

• Ventricular brillation with average amplitude less than 0.1 mV

• Ventricular tachycardia with heart rate less than 180/min

With the above analysis result, energy is not charged automatically. Perform

appropriate treatment according to emergency life saving protocol. If the patient

condition changes, perform AED analysis again and follow the physician’s

instruction.

NOTE

• If the amplitude of a waveform is very small, the waveform may not be

judged as a shockable rhythm and automatic energy charging may not

be performed.

Automatic energy charging standard is:

- Ventricular fibrillation with average amplitude not less than 0.1 mV, or

- Ventricular tachycardia with heart rate not less than 180/min

• When small amplitude ventricular fibrillation is not judged to be a

shockable rhythm, follow the physician’s instruction and continue the

appropriate treatment. By continuing CPR, the amplitude of ventricular

fibrillation may become large and reanalysis may start automatic

energy charging.




5

Section 5 Pacing (TEC-5531 Only)

About Pacing .......................................................................................................................................................5.2

Important Safety Information ...............................................................................................................................5.3

Pacing in FIXED Mode ........................................................................................................................................5.4

Information on the Pacing Screen in FIXED Mode .................................................................................... 5.4

Procedure ..................................................................................................................................................5.4

Pacing in DEMAND Mode .................................................................................................................................5.11

Information on the Pacing Screen in DEMAND Mode ............................................................................. 5.11

Procedure ................................................................................................................................................5.12




5. PACING (TEC-5531 ONLY)

About Pacing

Noninvasive xed and demand pacing is only available with the TEC-5531

debrillators. After debrillation, if bradycardia is observed, immediate electric

stimulation can be given through the patient’s chest with the disposable pads.

The ECG waveforms during pacing can be monitored continuously with the

ECG connection cable and disposable electrodes.

Two pacing modes are provided with the TEC-5531 debrillators.

FIXED mode: Pacing current is output at the selected pacing rate.

DEMAND mode: When there is no spontaneous heart beat, pacing current

is output at the selected pacing rate. When there is a

spontaneous heart beat and the next heart beat does not

occur, pacing current is output at the selected pacing rate.



5




WARNING

Do not perform pacing while using an ESU.Before using the ESU, turn the defibrillator power

off and remove disposable pads from the patient.

Otherwise, high frequency energy from the ESU

causes abnormal current to flow into the patient

and causes electrical burn, shock or other injury.

It also damages the defibrillator.

WARNING

Always monitor the ECG waveform with the ECGconnection cable and ECG electrodes.

WARNING





WARNINGFailure to follow the warnings below may cause
















protective sheet.




WARNING


may be misrecognized as QRS and correct

pacing cannot be performed.

WARNING




CAUTIONWhen using the disposable pads for long term





CAUTIONDo not put heavy objects on the disposable pads



patient.

CAUTION



CAUTION



NOTE

Follow all disposable pad labeling instructions.





Pacing in FIXED Mode

Information on the Pacing Screen in FIXED Mode

The following information can be displayed on the pacing screen in FIXED

mode.

Heart rate

ECG lead

QRS sync mark AC power operation

Pacing mode

Pacing current

Pacing rate

ECG sensitivity

ECG waveform

Pacing pulse output point

This is the pacing screen in FIXED mode which appears when neither SpO 2 nor

CO2 are monitored.

Procedure




Paddle release knob




5



CAUTION



or damaged.

2. Turn the Energy/Mode Select control to the FIXED position to turn the

power on. Conrm that the “Fixed” message appears and there is no error

message on the screen. For error messages, refer to Section 9.

3. Prepare the patient to monitor the ECG waveforms with the debrillator.


front panel.

ii) Attach the disposable ECG monitoring electrodes to the patient. Refer to

“Preparing for ECG Monitoring” in Section 6-2.

NOTE

• Do not attach the ECG monitoring electrodes where the

disposable pads will be attached.

• If the disposable pads and ECG monitoring electrodes are

placed near each other, noise by pacing pulse becomes large

and ECG cannot be observed. If the noise is large, change the

ECG electrode position and ECG lead.




Usually “II” is selected.

WARNING






NOTE







5. Select the pacing rate with the PACING RATE Up/Down key. The selected

rate appears at the lower right corner of the screen.





WARNING

The pacing rate must be determined by qualified medical personnel

based on the heart rate of the patient in a normal state.

6. Select 0 mA with the PACING OUTPUT Up/Down key. Conrm that theFIXED mode is selected.


WARNING




• Do not reuse disposable pads.• If the pad package is torn, dispose of the pads









edges of the pad, etc).• Do not use the disposable pads if the gel


protective sheet.

WARNING




WARNING





CAUTION






CAUTION




patient.

CAUTION



NOTE


the pads is dry, deteriorated or discolored.





5





NOTE





WARNING

Failure to follow the following warnings causes serious skin burn.

• Do not attach the pads over ECG electrode.

• Do not attach pads on the papilla or medicine on the patient’s

body.


uniformly through the pad. This reduces the required pacingcurrent and pain and discomfort to the patient.

CAUTION




Anterior-Apex placement










WARNING

The apex-posterior placement is not suitable for ECG monitoring orAED analysis.

Anterior-Posterior placement

RA: Between left scapula and spine

LL: Fifth middle axial line

WARNINGThe anterior-posterior placement is not suitable for ECG monitoring

or AED analysis. Use this placement only for pacing.



5




NOTE







8. Press the START/STOP key to start pacing. The “Now Pacing” message

appears.

9. Gradually increase the pacing current with the PACING OUTPUT Up/Down

key. The pacing current appears at the lower right corner of the screen. When

a pacing pulse is output, the PULSE lamp lights and a “ ” mark appears

below the ECG waveforms.

WARNING



WARNING




WARNING



WARNING



CAUTION







NOTE

• When the pacing intensity is set to 0 mA, the PULSE lamp does not

light.

• Pacing is not performed for 3 seconds after the START/STOP key is

pressed.

• When the pacing intensity is set to under 10 mA, the “Pacing

stopped. (paddle disconnected)” message may not be displayed.

Always check the pacing effect on the screen.

• When the pad-skin contact impedance is high, pacing may stop and

the “Pacing stopped. (paddle disconnected)” message may appear.

To solve this, refer to Section 9.

To stop pacing, press the START/STOP key or select 0 mA with the

PACING OUTPUT Up/Down key.

NOTE

When you stop pacing by selecting 0 mA with the PACING OUTPUT

Up/Down key, pacing restarts when you select another intensity with

the PACING OUTPUT Up/Down key.

10. Turn the Energy/Mode Select control to the OFF position. Press the paddle

release knob of the paddle connector on the front panel and remove the pad

adapter from the paddle connector. Dispose of the disposable pads and the

electrodes too.

NOTE







5



Pacing in DEMAND Mode

Information on the Pacing Screen in DEMAND Mode

The following information can be displayed on the pacing screen in DEMAND

mode.

ECG lead

Heart rate

QRS sync mark

QRS wave detection point

Spontaneous ECG

AC poweroperation

Pacing mode

Pacing current

Pacing rate

ECG sensitivity

Pacing pulseoutput point

This is the pacing screen in DEMAND mode which appears when neither SpO2

nor CO2 is monitored.





Procedure

WARNING

Confirm that there is no noise on the ECG. Noise may be

misrecognized as QRS and discharge might not synchronize with



i) Press the paddle release knob of the paddle connector on the right panel


Paddle release knob


CAUTION



or damaged.

2. Turn the Energy/Mode Select control to the DEMAND position to turn the

power on. Conrm that the “Demand” appears and that there is no error

message on the screen. For error messages, refer to “Messages” in Section 9.

3. Prepare the patient to monitor the ECG waveforms with the debrillator.


front panel.

ii) Attach the disposable ECG monitoring electrodes to the patient. Refer to

“Preparing for ECG Monitoring” in Section 6-2.



5



NOTE

• Do not attach the ECG monitoring electrodes where the

disposable pads will be attached.

• If the disposable pads and ECG monitoring electrodes are

placed near each other, noise from the pacing pulse becomes

large and ECG cannot be observed. If the noise is large,

change the ECG electrode position and ECG lead.




Usually “II” is selected.

WARNING






NOTE







5. Select the pacing rate with the PACING RATE Up/Down key. The selected

rate appears in the lower right corner of the screen.

WARNING

The pacing rate must be determined by qualified medical personnel

based on the heart rate of the patient in a normal state.

6. Select 0 mA with the PACING OUTPUT Up/Down key. Conrm that

DEMAND mode is selected.






WARNING

















protective sheet.

WARNING




WARNING





CAUTION



Failure to follow this instruction may causeinsufficient pacing current and insufficient energy


CAUTION



and deteriorated, resulting in skin burn on thepatient.

CAUTION



NOTE

• Always have spare disposable pads. Use the spare pads if the gelof the original pads is dry, deteriorated or discolored.





5





NOTE





WARNING

Failure to follow the following warnings causes serious skin burn.

• Do not attach the pads over ECG electrode.

• Do not attach pads on the papilla or medicine on the patient’s

body.


uniformly through the pad. This reduces the required pacing

current and pain and discomfort to the patient.

CAUTION




Anterior-Apex placement

RA: Right side of sternum and below the clavicleLL: On the level of fifth intercostal space and midaxillary line








WARNING

The apex-posterior placement is not suitable for ECG monitoring orAED analysis.

Anterior-Posterior placement

RA: Between left scapula and spine

LL: Fifth middle axial line

WARNING

The anterior-posterior placement is not suitable for ECG monitoring or

AED analysis. Use this placement only for pacing.



5




NOTE







8. Check that the “ ” mark appears on every QRS wave.

The “ ” mark indicates that the debrillator detects the QRS wave. If the

mark does not appear:


key.



9. Press the START/STOP key to start pacing. The “Now Pacing” message

appears.

10. Gradually increase the pacing current with the PACING OUTPUT Up/Down

key until QRS by pacing appears on the screen. The pacing current appears

in the lower right corner of the screen. When a pacing pulse is output, the

PULSE lamp lights and a “ ”mark appears below the ECG waveforms.

WARNING



WARNING




WARNING

Do not change the sensitivity or ECG lead setting

after pacing is started. If sensitivity or lead is

changed, the pacing stops for 3 seconds. Failure

to follow this warning may cause serious heartattack.

WARNING







WARNING



WARNING

No QRS wave is detected:


the pacing rate is set to 100 ppm or more.


the pacing rate is set to 90 ppm or less.

CAUTION



NOTE

• The paced QRS wave may not be counted correctly.

• When the pacing intensity is set to 0 mA, the PULSE lamp does not

light.• Pacing is not performed for 3 seconds after the START/STOP key is

pressed.

• When the pacing intensity is set to under 10 mA, the “Pacing

stopped. (paddle disconnected)” message may not be displayed.

Always check the pacing effect on the screen.

• When the pad-skin contact impedance is high, pacing may stop and

the “Pacing stopped. (paddle disconnected)” message may appear.

To solve this, refer to Section 9.

To stop pacing, press the START/STOP key or select 0 mA with the

PACING OUTPUT Up/Down key.

NOTE

When you stop pacing by selecting 0 mA with the PACING OUTPUT

Up/Down key, pacing restarts when you select another intensity with

the PACING OUTPUT Up/Down key.

11. Turn the Energy/Mode Select control to the OFF position. Press the paddle

release knob of the paddle connector on the front panel and remove the pad

adapter from the paddle connector. Dispose of the disposable pads and the

electrodes.

NOTE








6

6-1

6-2

6-3

6-4

Section 6 Monitoring

Section 6-1 General ........................................................................................................................................6-1.1

Section 6-2 ECG Monitoring ...........................................................................................................................6-2.1

Section 6-3 SpO2 Monitoring ..........................................................................................................................6-3.1

Section 6-4 CO2 Monitoring ............................................................................................................................6-4.1




6

Section 6-1 General

General .............................................................................................................................................................6-1.2

Displaying the Monitoring Screen ...........................................................................................................6-1.2

Screen Examples ...................................................................................................................................6-1.2

6-1




6. MONITORING

General

ECG, SpO2 and CO2 can be monitored with this debrillator. When monitoring

starts, waveforms, measurement value of each parameter and/or bar graphs for

CO2 or SpO2 are displayed on the screen.

Displaying the Monitoring Screen

To display the monitoring screen, turn the Energy/Mode Select control to the

MONITOR position. You can select the display parameters in the Setup - Date/

Screen screen.

Screen Examples

Monitoring ECG (2nd wave setting: off) Monitoring ECG and CO2 (2nd wave setting: off)

Heart rate ECG lead

QRS sync markECG sensitivity

ECG waveform

Respiration rateCO2 value

CO2 bar graph




6-1. GENERAL

6-1

Monitoring ECG, SpO2 and CO2 (2nd wave setting: SpO2/CO2) Monitoring ECG and SpO2 (2nd wave setting: SpO2)

SpO2 waveform

SpO2 value Pulse rate

Monitoring ECG and CO2 (2nd wave setting: CO2) Monitoring ECG, SpO2 and CO2 (2nd wave setting: SpO2/CO2)

CO2 waveform

SpO2 bar graph

6




6

6-2

Section 6-2 ECG Monitoring

Preparing for ECG Monitoring ..........................................................................................................................6-2.3

Preparation Flowchart ............................................................................................................................6-2.3

Selecting a Lead.....................................................................................................................................6-2.3

Number of Electrodes and Measuring Leads ......................................................................................... 6-2.4

Electrode Position...................................................................................................................................6-2.4

3 Electrode Leads ........................................................................................................................6-2.4

5 Electrode Leads ........................................................................................................................6-2.5

Selecting Electrodes and Lead ...............................................................................................................6-2.6

Types of Electrodes and Lead ......................................................................................................6-2.6

Connecting the ECG Connection Cable or the JC-762V/JC-763V Connection Cable to theDefibrillator .............................................................................................................................................6-2.7

Connecting the ECG Connection Cable to the Defibrillator .........................................................6-2.7

Connecting the JC-762V/JC-763V Connection Cable to the Defibrillator ....................................6-2.7

Attaching Disposable ECG Electrodes to the Patient ............................................................................. 6-2.7

Monitoring ECG with Disposable Pads...................................................................................................6-2.8

Monitoring ECG ..............................................................................................................................................6-2.10

ECG Information on the Monitoring Screen .........................................................................................6-2.10

Selecting an ECG Lead ..................................................................................................................................6-2.11

Selecting ECG Sensitivity ...............................................................................................................................6-2.12

Automatically Adjusting ECG Sensitivity .................................................................................... 6-2.12Changing ECG Settings .................................................................................................................................6-2.13

Changing Settings on the ECG Setup Screen .....................................................................................6-2.13

Turning the AC Hum Filter On or Off .......................................................................................... 6-2.14

Changing the Time Constant Setting .........................................................................................6-2.15

Turning Pacing Pulse Rejection On or Off .................................................................................. 6-2.16

Changing Heart Rate Upper or Lower Limit ............................................................................... 6-2.17

Changing Settings on the QRS Setup Screen .....................................................................................6-2.18

Changing QRS Sync Sound Volume .......................................................................................... 6-2.19

Changing QRS Sync Sound Source ..........................................................................................6-2.19

Turning the VF/VT Alarm On or Off ............................................................................................ 6-2.20

Use with an Electrosurgical Unit .....................................................................................................................6-2.21




6. MONITORING

ECG is monitored by attaching disposable electrodes to the patient and

connecting to the ECG input connector on the front panel. ECG is also monitored

by attaching disposable pads to the patient and selecting PADDLE for the ECG

lead. ECG waveform and heart rate are displayed.



6


6-2. ECG MONITORING

6-2

Preparing for ECG Monitoring

Preparation Flowchart

1. Select the disposable ECG electrodes and ECG connection cable.

2. Connect the ECG connection cable to the ECG input connector on the

debrillator.

3. Attach the disposable ECG electrodes to the patient and attach the ECG

connection cable to the electrodes.

4. Monitoring starts. Set necessary settings.

For handling accessories after use, refer to Section 10 “Maintenance”.

Selecting a Lead

NOTE

Follow the physician’s instructions for lead position when available.

Select the optimum lead according to the following guidelines:

• Select the lead with the highest QRS wave amplitude and least difference in

amplitude compared with a VPC or pacing pulse.

0.5 ≤ QRS1/QRS2 ≤ 2

• Select a lead with less than 0.2 mV amplitude of the P-wave (with the

sensitivity ×1 and P amplitude is less than 2 mm on the screen).

P ≤ 0.2 mV

• Select a lead with a T-wave amplitude which is less than one-third of the QRS

wave.

T1 ≤ 1/3QRS1, T2 ≤ 1/3QRS2

P T1

QRS1

T2

QRS2




6. MONITORING

Number of Electrodes and Measuring Leads

The leads which can be monitored differ according to the type of ECG

connection cable or electrode lead and number of electrodes used.

Lead Features

3 electrodes I, II, III Can measure at the thoracic wall.

5 electrodes I, II, III, aVR, aVL, aVF, V(V is one of V1 to V6)

Similar to the standard 12 lead.

Electrode Position

NOTE

• When attaching ECG electrodes for synchronized cardioversion or

external pacing, avoid positions where paddles or pads are placed.

• When electrodes cannot be attached to the positions shown below (for

example because of chest operation), a relatively stable ECG waveformcan be obtained by attaching electrodes on both shoulder joints.

3 Electrode Leads

Electrode Position

Symbol Lead Color (Clip Color) Electrode Position

R

RA

Red (Red-beige)

White (White-beige)Right infraclavicular fossa

L

LA

Yellow (Yellow-beige)

Black (Black-beige)Left infraclavicular fossa

FLL

Green (Green-beige)Red (Red-beige)

Lowest rib on the left anterioraxillary line

Lead Connection

Lead I Lead II Lead III

R/RA L/LA

F/LL

R/RAR/RA L/LAL/LA

F/LLF/LL

R/RA L/LA

F/LL



6


6-2. ECG MONITORING

6-2

5 Electrode Leads

Electrode Position

Symbol Lead Color (Clip Color) Electrode Position

R

RA

Red (Red-beige)

White (White-beige)Right infraclavicular fossa

L

LA

Yellow (Yellow-beige)

Black (Black-beige) Left infraclavicular fossa

F

LL

Green (Green-beige)

Red (Red-beige)

Left midclavicular line about 12-15 mm

above the iliac crest or the left edge of

the backbone about 12-15 mm above

the iliac crest.

N (RF)

N (RL)

Black (Black-beige)

Green (Green-beige)

Right anterior axillary line at the same

level as F.

C

V

White (Brown-white)

Brown (Blue-brown)

Any one of the C1 to C6

C1 (V1): Fourth intercostal space

at the right border of the

sternum

C2 (V2): Fourth intercostal space at

the left border of the sternum

C3 (V3): Halfway between C2 (V2)

and C4 (V4)

C4 (V4): Fifth intercostal space on left

midclavicular line

C5 (V5): Left anterior axial line at the

horizontal level of C4 (V4)

C6 (V6): Left midaxillary line at the

horizontal level of C4 (V4)

Lead Connection

Lead I Lead II Lead III

aVR lead aVL lead aVF lead

V1 to V6 leads

to

R/RA

R/RA

R/RA R/RA R/RA

R/RAR/RAL/LA

L/LA

L/LA

L/LAL/LA

L/LAL/LA

F/LL

F/LL

F/LLF/LL F/LL

F/LLF/LL

N(RF/RL)

N(RF/RL)

N(RF/RL) N(RF/RL) N(RF/RL)

N(RF/RL)N(RF/RL)

Standard limb leads

Monopolar limb leads

Monopolar chest leads

R/RA L/LA

N (RF/RL) F/LL

C1/V1 C2/V2

C3/V3

C4/V4C5/V5

C6/V6




6. MONITORING

Selecting Electrodes and Lead

Select the appropriate disposable ECG electrodes and ECG connection cable or

electrode lead according to the number of electrodes (lead).

WARNING

When using a defibrillator together with the monitor, use Ag/AgCl

electrodes. Other types of electrodes, stainless steel in particular, will

adversely affect the ECG waveform by slowing the baseline recovery

on the monitor and result in no monitoring immediately following

defibrillation.

CAUTION

Only use Nihon Kohden products and specified parts and

accessories. When other parts are used, the defibrillator may

overheat and be damaged and monitoring may stop.

Types of Electrodes and Lead

No. of Electrodes Disposable ElectrodesECG Connection Cable or

Electrode LeadConnection Cable

3

(I, II, III)

Vitrode C-150

(Recommended)

ECG connection cable BC-763V

Not necessary

Electrode lead BR-018P, BR-019P,

BR-024P, BR-033P, BR-034P, BR-

903P

JC-762V/763V connection

cable

Example: JC-762V

5

(I, II, III, aVR, aVL,

aVF, any one of the

V1 to V6)

ECG connection cable BC-765V

Not necessary

Electrode lead BR-020P, BR-021P,

BR-026P

JC-762V connection cable



6


6-2. ECG MONITORING

6-2

Connecting the ECG Connection Cable or the JC-762V/JC-763V Connection Cable to

the Defibrillator

Connecting the ECG Connection Cable to the Defibrillator

Connect the ECG connection cable to the ECG input connector on the front

panel of the debrillator.

Connecting the JC-762V/JC-763V Connection Cable to theDefibrillator

1. Connect electrode leads to the connector of the JC-762V or JC-763V

connection cable.

2. Connect the JC-762V or JC-763V connection cable to the ECG input

connector on the front panel of the debrillator.

Attaching Disposable ECG Electrodes to the Patient

CAUTION

Do not reuse disposable items.

NOTE

• To maintain good contact between the electrode and skin, check that

the paste of the disposable ECG electrode is not dry.

• When contact of the disposable ECG electrode becomes poor,

replace the electrode with a new one immediately. Otherwise, contact

impedance between the skin and electrode increases and the correct

ECG cannot be obtained.

• If the contact is bad before the expiration date on the package, replace

the electrode with a new one.




6. MONITORING

1. Shave excess hair. With a piece of cotton pad moistened with alcohol, clean

the patient’s skin where the electrodes should be attached. Avoid wrinkled or

uneven skin areas. Wipe off the alcohol with a dry cotton pad.

NOTE

To obtain a stable ECG waveform rub the skin with “Skinpure” skin

preparation gel.

2. Open the disposable electrode package and take out the electrode.

3. Remove the gel cover from the electrode. Be careful not to touch the

adhesive side.

4. Attach the disposable ECG electrode to the previously cleaned skin. Avoid

wrinkled and uneven skin areas.

NOTE

If the contact becomes bad because of sweat or body movement,

replace the electrode with a new one.

5. Clip the electrode lead or ECG connection cable onto the electrode.

NOTE

Check that electrodes are not pulled by the ECG connection cable or

electrode lead.

6. Fasten the electrode lead to the skin with surgical tape with an extra length

of wire between the tape and the electrode. This prevents body movement

from moving the electrode lead.

Monitoring ECG with Disposable Pads

You can monitor patient’s ECG using the disposable pads instead of ECG

monitoring electrodes. However, 3 electrode lead ECG and 5 electrode lead ECG

are not available with disposable pads.

For connecting the pad adaptor to the debrillator, attaching the disposable

pads to the patient and attachment site, refer to Section 4 “Debrillation,

Synchronized Cardioversion and AED”.

Extra length



6


6-2. ECG MONITORING

6-2

WARNING
















protective sheet.

WARNING





internal paddles. If ECG is monitored with padsor paddles, high frequency energy from the ESU



defibrillator.

WARNING




CAUTION






CAUTION




patient.

CAUTION



CAUTION

When you monitor ECG that is acquired with

the disposable pads, check the polarity of the

pads before attaching them on the patient. If the

pad polarity is incorrect, the waveform appears

upside-down and this may cause incorrect

judgment by the operator and delay of treatment.

NOTE







6. MONITORING

Monitoring ECG

When electrodes are attached to the patient and cables are connected properly,

ECG appears on the screen.

CAUTION

When the “Check ECG Electrodes” message is displayed, ECG is

not monitored properly and the ECG alarm does not function. Check

the electrode, electrode leads and connection cord, and if necessary,

replace with new ones.

ECG Information on the Monitoring Screen

Heart rate

ECG Lead

QRS sync mark

ECG waveform

Sensitivity




6. MONITORING

Selecting ECG Sensitivity

Select the sensitivity of the ECG waveform to be monitored. This sensitivity is

applied to the QRS detection sensitivity. For stable QRS detection, select the

sensitivity so that the amplitude of the QRS is larger than 1 cm.

Setting range: ×1/4, ×1/2, ×1 (default setting), ×2, ×4, AUTO*

* AUTO can only be selected in monitoring mode.

Press the ECG Sensitivity key on the front panel to change the ECG sensitivity.

When the key is pressed, sensitivity changes as below.

Monitor mode: ×1/4 → ×1/2 → ×1 → ×2 → ×4 → AUTO → ×1/4

Debrillation, pacing, AED, paddle lead mode:

×1/4 → ×1/2 → ×1 → ×2 → ×4 → ×1/4

Automatically Adjusting ECG Sensitivity

When you select AUTO sensitivity, the appropriate sensitivity is automatically

selected and displayed on the screen. When sensitivity is set automatically, “AG

(auto gain)” appears beside the sensitivity at the upper left of the screen.

NOTE

AUTO sensitivity is not possible when there is noise.

QRS waveform amplitude and selected sensitivity

QRS Amplitude AUTO Sensitivity Display

< 5 mm 4 AG ×4

< 10 mm 2 AG ×2

< 20 mm 1 AG ×1

< 40 mm 1/2 AG ×1/2

More than 40 mm 1/4 AG ×1/4

When AUTO is selected in MONITOR mode and the screen changes to another

screen, sensitivity is xed to the sensitivity that was selected when you changed

to the other screen and it is no longer automatically adjusted even if you display

the monitor screen again.

(For example)

AG ×2 in MONITOR mode

↓

Screen changes to debrillation screen.

↓

×2 in debrillation mode

↓

Screen changes to MONITOR mode.

↓

×2 in MONITOR mode

(The sensitivity does not automatically return to AUTO.)



6


6-2. ECG MONITORING

6-2

Changing ECG Settings

The following settings can be changed for ECG monitoring. The default settings

are underlined.

Item Description

AC hum lter When set to “ON”, the hum lter

automatically reduces AC interference

from the ECG.

ON, OFF

Time Constant Set the time constant for ECG display in

MONITOR mode.

3.2 s, 0.32 s

Pacing Pulse Reject When set to “ON”, it allows correct

heart rate counting when the patient has

an implanted pacemaker.

ON, OFF

HR alarm Set the upper and lower limit of the

heart rate alarm.

Upper: 20 to 300, OFF (140)

Lower: OFF, 15 to 295 (40)

QRS Volume Set the QRS sync sound volume. 0 to 4 (3)QRS Sound Select the source of the QRS sync

sound.

ECG, SpO2

VF/VT Alarm Select whether or not to detect VF/VT. ON, OFF

Changing Settings on the ECG Setup Screen

1. Turn the Energy/Mode Select control to the SETUP position. The Setup

Menu screen appears.

2. Select “ECG Setup” with the Item ↓ or Item ↑ key and press the SET key.

The ECG Setup screen appears.




6. MONITORING

3. Press the Item key to select the item. When you press the key, selected item

switches.

4. Press the ↓ or ↑ key to change settings.


6. Turn the Energy/Mode Select control to the MONITOR position to return to

the monitoring screen appears.

Turning the AC Hum Filter On or Off

When “ON” is selected, the hum lter automatically reduces AC interference

from the ECG. This lter also prevents ECG baseline drift in MONITOR mode.

ON: AC interference is reduced. Select ON when there is much AC

interference or when using an electrosurgical unit. (Default setting)

OFF: AC interference is not reduced. Select when you want to monitor

unltered waveforms for example when examining a QRS change in

ECG.

NOTE

• The AC hum filter is fixed to ON when PADDLE is selected as an ECG

source lead.

• When the hum filter is set to ON, some QRS waveforms are distorted

greatly.

1. On the ECG Setup screen, select AC hum lter with the Item key.




6


6-2. ECG MONITORING

6-2

Changing the Time Constant Setting

When ECG baseline drift is large, set the Time Constant to 3.2 s (Default setting:

0.32 s).

NOTE

• The Time Constant is fixed to 0.32 s when PADDLE is selected as an

ECG source lead.

• The Time Constant is fixed to 3.2 s when AUX is selected as an ECG

source lead.

1. On the ECG Setup screen, select Time Constant with the Item key.

2. Select 0.32 s or 3.2 s or with the ↓ or ↑ key.




6. MONITORING

Turning Pacing Pulse Rejection On or Off

This setting selects whether or not to reject pacemaker spike counting and allow

correct heart rate counting when monitoring the patient who has an implanted

cardiac pacemaker.

ON: Reject pacemaker spike counting and allow correct heart rate counting.

Select ON when the patient has an implanted cardiac pacemaker. When thedebrillator detects an implanted pacemaker pulse output, “ ” is displayed

below the waveform.

OFF: Pacing pulses are not detected. Select OFF when you monitor a premature

baby or infant and the debrillator miscounts the narrow width QRS.

(Default setting: OFF)

WARNING

Even when the pacing pulse rejection is set to

ON, the pacemaker pulse can be overlooked

or detected as QRS. You cannot confirm the

pacemaker operation only from the detected

pacemaker pulse.

WARNING

Turn pacing pulse rejection to OFF when

monitoring a child, baby or infant. When pacing

pulse rejection is set to ON, narrow width QRS

of a child cannot be detected correctly and the

defibrillator may miscount QRS.

CAUTION

Turn the pacing pulse rejection to On when

monitoring a pacemaker patient. Otherwise QRS

and pacemaker pulse might not be distinguished

and pacing failure* might not be recognized.

* Pacing failure is a state where pacing spike is output but

ventricular or atrial reaction does not occur.

NOTE

PADDLE lead has low frequency characteristics. Therefore, when you

monitor a patient with an implanted pacemaker in PADDLE lead, a

pacemaker spike may be displayed like a QRS.

1. On the ECG Setup screen, select Pacing Pulse Reject with the Item key.




6


6-2. ECG MONITORING

6-2

Changing Heart Rate Upper or Lower Limit

Set the upper and lower limit of the heart rate alarm.

Setting range

Item Range Step Default Setting

HR (heart rate)

beat/min

Upper 20 to 300, OFF 5 140

Lower OFF, 15 to 295 5 40

NOTE

If you increase the upper limit over 300, the upper limit becomes OFF.

If you decrease the lower limit below 15, the lower limit becomes OFF.

CAUTION

When the alarm limit is set to OFF, there will be no alarm for that

limit. Be careful when you set the alarm limit to OFF.

1. On the ECG Setup screen, select the heart rate upper limit or lower limit of

the heart rate alarm with the Item key.

The arrow in the HR bar graph indicates the current heart rate.

2. Set the upper or lower limit with the ↓ or ↑ key.




6. MONITORING

Changing Settings on the QRS Setup Screen



2. Select “QRS Setup” with the Item ↓ or Item ↑ key and press the SET key.

The QRS Setup screen appears.

3. Press the Item key to select the item. When you press the key, selected item

switches.

4. Press the ↓ or ↑ key to change settings.


6. Turn the Energy/Mode Select control to the MONITOR position to return to

the monitoring screen.



6


6-2. ECG MONITORING

6-2

Changing QRS Sync Sound Volume

The QRS sync sound volume can be set from 0 to 4. (Default setting: 3)

1. On the QRS Setup screen, select QRS Volume with the Item key.

2. Select the volume with the ↓ or ↑ key.

Changing QRS Sync Sound Source

Select the QRS sync sound source from ECG or SpO2 (pulse wave). (Default

setting: ECG)

1. On the QRS Setup screen, select QRS Sound with the Item key.

2. Select the QRS sync sound source with the ↓ or ↑ key.




6. MONITORING

Turning the VF/VT Alarm On or Off

This debrillator can perform ECG background analysis to detect shockable

rhythm (ventricular brillation and ventricular tachycardia) in the monitor mode.

When this setting is set to ON, the “Check Patient” message appears on the

screen when a shockable rhythm is detected. (Default setting: ON)

NOTE

• When monitoring the ECG waveforms with the external paddles or

internal paddles, the VF/VT Alarm is turned off.

• In AED mode, the VF/VT Alarm is always turned on regardless of this

setting.

1. On the QRS Setup screen, select VF/VT Alarm with the Item key.




6


6-2. ECG MONITORING

6-2

Use with an Electrosurgical Unit

For use with an electrosurgical unit (ESU), this debrillator has a circuit to

protect the patient from skin burn and to reduce ESU interference on the ECG

waveform. However, the effectiveness of this circuit depends on electrode

position and debrillator setup. With an ESU, pay attention to the following

points.

WARNING

When the defibrillator is used with an electrosurgical unit (ESU),

firmly attach the entire area of the ESU return plate. Otherwise, the

current from the ESU flows into the electrodes of the deifbrillator,

causing electrical burn where the electrodes are attached. For

details, refer to the ESU manual.

WARNING

When using an ESU, use this defibrillator only in the MONITOR

mode and use the ECG electrodes for monitoring. Do not monitor

ECG with disposable pads, external paddles or internal paddles.

If ECG is monitored with pads or paddles, high frequency energy

from the ESU causes abnormal current to flow in the patient and

unexpected discharge. This may damage the defibrillator.

CAUTION

Install the defibrillator and ESU appropriately and perform

equipotential grounding. Otherwise, noise from the ESU may be

falsely recognized as QRS and ECG monitoring might not be

performed properly.

• Arrangement

Install the debrillator as far from the ESU as possible. If possible, locate them

on opposite sides of the operating table.

• Power Supply

Noise from the ESU may interfere with the ECG signal through the AC power

line. Supply power to the debrillator and ESU from different outlets located

as far from each other as possible. Do the equipotential grounding properly.

Defibrillator

3 electrodes

Grounding ESU

ESU

Bed

Grounding defibrillator




6. MONITORING

• Measure with 3-electrode Lead

Use the minimum number of electrodes. Use new electrodes whose gel is not

dry.

• Minimizing Noise

1. Select an ECG lead where the active ECG electrodes are located as far

from the incision as possible.

2. Position the + and – electrodes as close as possible.

3. Select the leads where the angle (θ) between the active electrodes and the

incision is as small as possible.

4. Set the electrosurgical return plate as close to the incision as possible.

Make this angle (θ) small.

As far as possible from electrode and

as near as possible to incision.

Return plateIncision

• Monitor pulse rate by measuring SpO2. The heart rate is unstable because of an

ESU.

• Set the following items on the ECG Setup screen.

AC Hum lter: ON

Time constant: 0.32 s




6

Section 6-3 SpO2 Monitoring

General .............................................................................................................................................................6-3.2

Preparing for SpO2 Monitoring ..........................................................................................................................6-3.5


Selecting a Probe ...................................................................................................................................6-3.5

Reusable Probes ..........................................................................................................................6-3.5

Disposable Probes .......................................................................................................................6-3.6

Connecting Probe to Defibrillator ...........................................................................................................6-3.7

Attaching the Probe to the Patient ..........................................................................................................6-3.7

Monitoring SpO2 ..............................................................................................................................................6-3.9

SpO2 Information on the Monitoring Screen ...........................................................................................6-3.9 Changing SpO2 Settings ................................................................................................................................6-3.10

Changing Settings on the SpO2 Setup Screen ..................................................................................... 6-3.10

Changing the Pulse Waveform Sensitivity .................................................................................. 6-3.11

Selecting Sync Sound Pitch .......................................................................................................6-3.12

Changing the Pulse Rate Alarm Limits ......................................................................................6-3.13

Changing the SpO2 Alarm Limits................................................................................................6-3.14

Changing QRS Sync Sound Volume ....................................................................................................6-3.14

Changing QRS Sync Sound Source ....................................................................................................6-3.146-3




6. MONITORING

General

SpO2 is monitored by attaching a probe to the patient and connecting the SpO2

adapter cable to the SpO2/CO2 connector on the debrillator. For proper SpO2

probe attachment and use, refer to the operator’s manual of the SpO2 probe.

WARNING

SpO2 measurement may be incorrect in the

following cases.

• When the patient’s carboxyhemoglobin or

methemoglobin increases abnormally.

• When dye is injected in the blood.

• When using an electrosurgical unit.

• During CPR.

• When measuring at a site with venous pulse.

• When there is body movement.

• When the pulse wave is small (insufficient

peripheral circulation).

WARNING






probe). The skin temperature may increase at the

attached site by 2 or 3°C (4 or 5°F) and cause a








skin

WARNING





blood circulation.

• When using probes other than the TL-201T

finger probe, to avoid poor circulation, do


circulation condition by observing the skincolor and congestion at the skin peripheral to




on neonates or low birth weight infants whose

skin is delicate. Accurate measurement cannot

be performed on a site with poor peripheral

circulation.

WARNING

When not monitoring SpO2, disconnect the SpO2

connection cord from the defibrillator. Otherwise,

noise from the probe sensor may interfere and

incorrect data is displayed on the screen.

WARNING

When measuring SpO2 of a patient who is in

a state of shock or in CPR (cardiopulmonary

resuscitation), the acquired SpO2 data may be

incorrect due to the patient’s body movement.

WARNING

When monitoring SpO2 of a patient who is

receiving photodynamic therapy, the light from

the finger probe sensor may cause a burn.

Photodynamic therapy uses a photosensitizing

agent that has a side effect of photosensitivity.

The SpO2 probe manufactured by Nihon Kohden have two

wavelengths with peaks in the range of 650 and 950 nm. The

maximum light intensity is less than 5.5 mW.




6-3. SpO2 MONITORING

6-3

CAUTION

Handle the probe cable according to the following

cautions. Failure to follow these cautions may

cause cable discontinuity or short circuit of

the probe cable which may cause incorrect

measurement data or inability to performmeasurement. Also in rare cases, the probe

temperature may increase and cause skin burn

on the patient. If the probe cable is damaged,

replace the probe with a new one.

• Do not pull or bend the probe cable.

• Do not let caster feet run over the probe cable.

CAUTION





the hospital administrator). Radio waves fromdevices such as mobile phones or small wireless

devices may be mistaken as pulse waves and the

displayed data may be incorrect.

CAUTION

Do not immerse the disposable probe in

detergent or water. If the probe adhesive surface

gets wet, the adhesiveness becomes weak and

the probe cannot be attached to the skin. Also,

it may cause incorrect data and skin burn on the

patient.

CAUTION

Only use the specified probes. Otherwise SpO2

cannot be monitored properly and instrument

performance may be degraded.

CAUTION

Do not use a probe which is deteriorated

by aging. Accurate measurement cannot be

performed.

CAUTION

Do not use a damaged or disassembled probe.

It causes incorrect measurement and may injure

the patient.

CAUTION

The disposable probe is not sterilized. Use the

disposable probe only for a single patient. Never

reuse the disposable probe for another patient

because it causes cross infection.

CAUTION

Normal external light does not affect monitoring

but strong light such as a surgical light or sunlight

may affect monitoring. If affected, cover the

measuring site with a blanket.

CAUTION

While a patient is on medication which causes

vasodilation, the pulse waveform may change

and in rare cases the SpO2 value might not be

displayed.

CAUTION







performed.

6




6. MONITORING

CAUTION





CAUTION





be correct. Attach the probe to a limb where theblood circulation is not affected.





details.

CAUTION





delicate.

CAUTION

When removing the probe from the attachment







6-3

Preparing for SpO2 Monitoring


1. Select the probe.

2. Connect the probe to the SpO2 adapter and connect the SpO2 adapter to the

SpO2/CO2 connector on the debrillator.

3. Attach the probe to the patient.

4. Monitoring starts. Set necessary settings.

For handling accessories after use, refer to Section 10 “Maintenance”.

Selecting a ProbeSelect the appropriate probe according to the purpose.

CAUTION

Only use the specified probes. Otherwise SpO2 cannot be monitored

properly and instrument performance may be degraded.

CAUTION

Do not use a probe which is deteriorated by aging. Accuratemeasurement cannot be performed.

CAUTION

Do not use a damaged or disassembled probe. It causes incorrect

measurement and may injure the patient.

Reusable Probes

Model Subject (Weight) Attachment Site SpO2 Adapter

Finger Probe TL-201T Adults, children

(Weight 20 kg or more)

Finger

JL-550T2

Multi-site Probe TL-220T Adults, children


Finger or toe

Neonates(Weight 3 kg or less)

Instep and sole

6




6. MONITORING

Disposable Probes

CAUTION

The disposable probe is not sterilized. Use the disposable probe only

for a single patient. Never reuse the disposable probe for another

patient because it causes cross infection.

Model Subject (Weight) Attachment Site SpO2 Adapter

TL-271T Adults


Finger or toe

JL-550T2

TL-272T Children

(Weight from 10 to 50 kg)

TL-273T Neonates

(Weight 3 kg or less)

Adults


Instep and sole

Finger or toe

TL-274T Infants


Finger or toe

TL-051S/052S

Cable length TL-051S: 80 cm

TL-052S: 160 cm

Adults(Weight 50 kg or more)

Finger

Neonates


Instep and sole

TL-061S/062S

Cable length TL-061S: 80 cm

TL-062S: 160 cm

Adults, children


Finger

Children, infants


Toe

TL-260T

Sponge attachmenttape

Neonates


Instep and

sole

Type L

attachment

tape

Children, neonates

(Weight 3 kg or more)Finger or

toe Type S

attachment

tapeLow birth weight infants

(Weight 1 kg or less)Instep and

sole





6-3

Connecting Probe to Defibrillator

1. Connect the probe to the sensor connector on the JL-550T2 SpO2 adapter.

Sensor connector

Lock cover

SpO2 adapter

2. Connect the JL-550T2 SpO2 adapter cable to the SpO2/CO2 connector on the

debrillator.

Attaching the Probe to the Patient

For proper SpO2 probe attachment and use, refer to the operator’s manual of the

SpO2 probe.

WARNING





blood circulation.

• When using probes other than the TL-201Tfinger probe, to avoid poor circulation, do


circulation condition by observing the skin

color and congestion at the skin peripheral to




on neonates or low birth weight infants whose

skin is delicate. Accurate measurement cannot

be performed on a site with poor peripheralcirculation.

WARNING






probe). The skin temperature may increase at theattached site by 2 or 3°C (4 or 5°F) and cause a








skin

CAUTION







performed.

CAUTION





6




6. MONITORING

CAUTION

When the probe is attached on an appropriate





CAUTION





be correct.Attach the probe to a limb where the blood

circulation is not affected.





details.

CAUTION





delicate.

CAUTIONWhen removing the probe from the attachment







6-3

Monitoring SpO2

When the preparation is done properly, the SpO2 value and pulse waveform

appear on the screen.

CAUTION

When the probe is attached on an appropriate





CAUTION

Alarms about a parameter do not occur until the

measurement of the parameter starts.

CAUTION

When a message indicates a faulty probe or

faulty SpO2 connection cable, replace the probe

or SpO2 connection cable with a new one.

NOTE

When the “Searching for SpO2 pulse” message is displayed for a long

time, it means that the detected pulse is too small to measure. Reposition

the probe.

SpO2 Information on the Monitoring Screen

Indicates that the upper or lower alarm limit is set to off.

SpO2 bar graph

When 2nd wave setting is CO2 or OFF

(Set on the Setup screen - Date/Screen)

SpO2 Pulse rate SpO2 waveform

2nd wave setting is SpO2, SpO2 /CO2 or SpO2 /CO2


When the SpO2 measurement is unstable, the “M” mark appears beside the SpO2

value.

6




6. MONITORING

Changing SpO2 Settings

The following settings can be changed for SpO2 monitoring. The default settings

are underlined.

Item Description

Sens Set the pulse wave sensitivity. AUTO, ×1/8, ×1/4, ×1/2, ×1,

×2, ×4, ×8

SpO2 Sound When set to ON, the pitch of the sync sound

changes according to SpO2 value.

ON, OFF

PR Set the upper and lower limit of pulse rate

alarm.

Upper: 20 to 300, OFF (140)

Lower: OFF, 15 to 295 (40)

SpO2 Set the upper and lower limit of the SpO2

alarm.

Upper: 51 to 100, OFF (OFF)

Lower: OFF, 50 to 99 (90)

QRS Volume Set the QRS sync sound volume. 0 to 4 (3)

QRS Sound Select the source of the QRS sync sound. ECG, SpO2

Changing Settings on the SpO2 Setup Screen



2. Select “SpO2 Setup” with the Item ↓ or Item ↑ key and press the SET key.

The SpO2 Setup screen appears.





6-3

NOTE

If an SpO2 probe is not connected to the SpO2 /CO2 connector on the

defibrillator, the SpO2 setup screen is not displayed. If the SpO2 setup

screen does not appear when an SpO2 probe is connected, turn the

Energy/Mode Select control to the MONITOR position, confirm the

SpO2 cable connection then turn the Energy/Mode Select control to

the SETUP position again.

3. Press the Item key to select the item. When you press the key, the selected

item switches.

4. Press the ↓ or ↑ key to change settings. Repeat steps 3 and 4 to set all items.

5. Turn the Energy/Mode Select control to the MONITOR position. The

monitoring screen appears.

Changing the Pulse Waveform Sensitivity

The sensitivity determines the size of the waveform on both the screen and

recording paper.

Setting range: AUTO, ×1/8, ×1/4, ×1/2, ×1 (default setting), ×2, ×4, ×8

When you select AUTO sensitivity, the appropriate sensitivity is automatically

selected.

1. On the SpO2 Setup screen, select Sens with the Item key.

2. Select the sensitivity with the ↓ or ↑ key.

AUTO → ×1/8 → ×1/4 → ×1/2 → ×1 → ×2 → ×4 → ×8

6




6. MONITORING

Selecting Sync Sound Pitch

When this item is set to ON, the pitch of the sync sound changes according to

SpO2 value, so you can know the SpO2 change by sound.

ON: The pitch of the sync sound changes as shown in the table below.

OFF: The pitch of the sync sound is xed. (Default setting)

SpO2 Tone

100% to 81% Changes in 20 steps corresponding to SpO2 value

(steps of 1).

80% or less Pitch for 81%

When the SpO2 adapter cable is disconnected from the debrillator, the sync

sound automatically becomes the pitch for OFF. When the SpO2 adapter cable is

connected again, the pitch returns to the previous pitch.

1. On the SpO2 Setup screen, select SpO2 Sound with the Item key.






6-3

Changing the Pulse Rate Alarm Limits

CAUTION



1. On the SpO2 Setup screen, select the upper or lower value of the pulse rate

(PR) limit with the Item key.

The arrow in the PR bar graph indicates the current pulse rate.

2. Select the upper or lower limit with the ↓ or ↑ key.

Item Range Step Default SettingPR

(beat/min)

Upper 20-300, OFF 5 140

Lower OFF, 15-295 5 40

NOTE



6




6. MONITORING

Changing the SpO2 Alarm Limits

CAUTION



1. On the SpO2 Setup screen, select the upper or lower SpO2 alarm limit with

the Item key.

The arrow in the SpO2 bar graph indicates the current SpO2 value.


Item Range Step Default SettingSpO2

(%)

Upper 51 to 100, OFF 1 OFF


NOTE



Changing QRS Sync Sound Volume

Refer to “Changing QRS Sync Sound Volume” in Section 6-2.

Changing QRS Sync Sound Source

Refer to “Changing QRS Sync Sound Source” in Section 6-2.




6

Section 6-4 CO2 Monitoring

General .............................................................................................................................................................6-4.2

CO2 Sensor Kit .......................................................................................................................................6-4.3

Preparing for CO2 Monitoring ...........................................................................................................................6-4.5


Connecting the CO2 Sensor Kit to the Defibrillator .................................................................................6-4.5

Monitoring CO2 ................................................................................................................................................6-4.6

CO2 Information on the Monitoring Screen .............................................................................................6-4.6

Changing CO2 Settings .....................................................................................................................................6-4.7

Changing Settings on the CO2 Setup Screen .........................................................................................6-4.7

Changing the CO2 Scale ..............................................................................................................6-4.8Changing the ETCO2 Alarm Limits ...............................................................................................6-4.9

Changing the Respiration Rate Alarm Limits .............................................................................6-4.10

Changing the APNEA Alarm Limit .............................................................................................6-4.11

Inspection of Measuring Accuracy..................................................................................................................6-4.12

Daily Inspection of Measuring Accuracy ..............................................................................................6-4.12

Inspection of Measuring Accuracy (Precise Method) ...........................................................................6-4.12

Checking Procedure ...................................................................................................................6-4.13

6-4




6. MONITORING

General

CO2 monitoring by the mainstream method is performed by connecting the TG-

901T3 or TG-921T3 CO2 sensor kit to the patient’s respiration circuit and to the

SpO2/CO2 connector on the debrillator. For the proper CO2 sensor attachmentand use, refer to the operator’s manual of the CO2 sensor.

WARNING

When performing defibrillation during CO2

monitoring with a CO2 sensor kit, remove the

sensor from the patient. If the sensor cannot be

removed, do not touch the sensor cable because

the discharged energy may cause electrical

shock or injury.

WARNING

With the TG-901T3 CO2 sensor kit,

measurements are based on the assumption

of no CO2 gas in the inspiration. The CO2

concentration in the respiration is calculated by

taking the CO2 concentration in the inspiration

as 0 mmHg. Therefore, measuring CO2 byconnecting the CO2 sensor kit to a patient under

mouth-to-mouth respiration or to a Jackson Rees

circuit or Mapleson D circuit where CO2 gas may

be present during inspiration may result in the

acquired data being lower than the actual value.

WARNING

With the TG-901T3 CO2 sensor kit, this

defibrillator cannot monitor CO2 of patients

weighing less than 10 kg (22 lbs).

WARNING



ventilation taking into consideration the 5 mL


due to the airway adapter s dead space, resulting


detecting apnea.

CAUTION

The CO2 data may be inaccurate when

monitoring a patient with an extremely high

respiration rate or irregular respiration. Read themeasured values carefully.

CAUTION

When using an anesthetic instrument with a

volatile anesthetic agent, the CO2 measurement

may be inaccurate.

CAUTION

The measured value may be incorrect when the

operating temperature changes greatly or there

is excess condensation in the airway adapter ornasal adapter.

NOTE

The measurement may be inaccurate when the defibrillator is used in thefollowing conditions. Read the measured values carefully.

• When there is high concentration nitrous oxide gas in the airway

adapter.




6-4. CO2 MONITORING

• When used in places with low atmospheric pressure such as at high

altitude.

• When used in environments with sudden temperature changes.

• When used in environments with severe humidity.

• When used for patients with irregular spontaneous respiration.

CO2 Sensor Kit

WARNING

Do not use the airway adapter on neonates

because the dead space volume of the airway

adapter is about 5 mL.

WARNING

Check that the oxygen cannula tube is not bent,

broken, or blocked by the nasal tube. If the ends

of the oxygen cannula tube turn too far up or

down, it causes insufficient O2 supply or the CO2

value may be incorrect.

WARNING



ventilation taking into consideration the 1.2 mL


due to the airway adapter’s dead space, resulting


detecting apnea.

WARNING

• When you use YG-122T together with an

oxygen cannula, check that the oxygen cannula

is correctly attached on the patient by referring

to other parameters and by observing the

patient periodically.

• If arterial oxygen partial pressure does not

increase, immediately stop using the oxygen

cannula with the CO2 sensor kit and select

another way to supply oxygen.

WARNING

The only oxygen cannula that can be used with

YG-122T is #1103 manufactured by HUDSON

RCI ® . Do not use any other oxygen cannula.

Other oxygen cannulas cannot be attached and

oxygen cannot be delivered to the patient through

the nostrils.

CAUTION

The airway adapter/nasal adapter is non-

sterilized and disposable. Use only for a single

patient and single use. Failure to follow this

instruction causes cross infection.

CAUTION

With the TG-901T3 CO2 sensor kit, secure the

CO2 sensor to the respiration circuit so that

the transparent film of the airway adapter is

perpendicular to the floor. If the transparent film is

parallel to the floor, water droplets may get onto

the transparent film and affect the measurement

accuracy.

6

6-4




6. MONITORING

CAUTION

Failure to follow the instructions below degrades

the anti-fogging ability of the transparent film and

results in incorrect measurement.


a new one every 24 hours.• Replace the airway adapter/nasal adapter with

a new one if blood, sputum or mucus adhere to

the transparent film.

• Do not damage the transparent film. Do not let

dust or detergent contact the transparent film.

Do not touch, wipe or clean the transparent film

with fingers or cleaners.

O P

E R / A L A R

M

C O 2

A D A

P T E R

TG-901T3 CO2 sensor kit YG-101T airway adapter


TG-101T CO2 sensor

Model Patient Weight Dead Space Volume Code No.

YG-101T Adult 10 kg or more 5 cc R801

H O P E R / A

L A

R M

C O

2 A D A

P T E

R

TG-921T3 CO2 sensor kit


TG-121T CO2 sensor

YG-121T

(for naso-oral)

YG-120T

(for nasal breathing)

Mouth guide

Holder for

oxygen cannula

Clip

Nasal tube

YG-111Tairway adapter

YG-122T

(for oxygen cannula)

Description Model Qty Code No.

Nasal adapter (for nasal breathing) YG-120T 30 V921

Nasal adapter (for naso-oral breathing) YG-121T 30 V922 Nasal adapter

(for oxygen cannula adjustment)YG-122T 30 V923

Airway adapter YG-111T 30 R804

The nasal adapters are for patients

over 3 years old or over 10 kg.




6-4. CO2 MONITORING

Preparing for CO2 Monitoring


1. Connect the CO2 sensor kit to the SpO2/CO2 connector on the debrillator.

2. Connect the CO2 sensor to the respiration circuit.

3. Start measurement and change necessary settings.

For handling accessories after use, refer to Section 10.

Connecting the CO2 Sensor Kit to the Defibrillator

Connect the CO2 sensor kit to the SpO2/CO2 connector on the debrillator.

6

6-4




6. MONITORING

Monitoring CO2

After completing the preparation, CO2 monitoring starts.

CAUTION

When the “CO2 sensor not working” or “CO2 adapter abnormality”

message is displayed, check the CO2 sensor kit and replace it if

necessary. CO2 cannot be monitored while the message is displayed.

NOTE

• When using the TG-901T3/TG-921T3 CO2 sensor kit, it performs

calibration automatically every minute and when any of the following

occurs.

- Defibrillator power on- Patient’s first respiration

- Airway adapter is removed from the CO2 sensor and connected again.

- Respiration stops for 20 seconds.

- Signal changes rapidly due to temperature change.

• During calibration, the CO2 waveform becomes flat (0 mmHg) but the

respiration rate and measured value are not affected.

CO2 Information on the Monitoring Screen

Indicates that the upper or

lower alarm limit is set to off.

CO2 bar graph

When the 2nd wave setting is SpO2 or OFF(Set on the Setup screen - Date/Screen)

CO2 value

Respiration rate

CO2 waveform

When the 2nd wave setting is CO2, SpO2 /CO2 orSpO2 /CO2





6-4. CO2 MONITORING

Changing CO2 Settings

The following settings can be changed for CO2 monitoring. The default settings

are underlined.

Item Description

Scale Set the scale of CO2 waveform.0 to 40, 0 to 80 (mmHg)

0 to 5.3, 0 to10.7 (kPa)

ETCO2

Set the upper and lower limit of the

CO2 alarm.

mmHgUpper: 2 to 99, OFF (50)

Lower: OFF, 1 to 98 (20)

kPaUpper: 1.0 to 13.5, OFF (7.0)

Lower: OFF, 0.5 to 13.0 (3.0)

RR Set the upper and lower limit of the

respiration rate alarm.

Upper: 2 to 150, OFF (OFF)

Lower: OFF, 0 to 148 (OFF)

APNEASet the upper limit of the APNEA

alarm.Upper: 5 to 40, OFF (OFF)

Changing Settings on the CO2 Setup Screen



2. Select “CO2 Setup” with the Item ↓ or Item ↑ key and press the SET key. The

CO2 Setup screen appears.

6

6-4




6. MONITORING

3. Press the Item key to select the item. When you press the key, the selected

item switches.

4. Press the key for “↓” or “↑” to change settings.


6. Turn the Energy/Mode select control to the MONITOR position to return to

the monitoring screen.

Changing the CO2 Scale

Select the appropriate scale for the patient CO2 waveform.

Setting range: 0 to 40, 0 to 80 (default setting)

(0 to 5.3, 0 to 10.7 when kPa is selected.)

1. On the CO2 Setup screen, select Scale with the Item key.

2. Select the scale with the ↓ or ↑ key.




6-4. CO2 MONITORING

Changing the ETCO2 Alarm Limits

Set the upper and lower limit for the ETCO2 alarm.

CAUTION



1. On the CO2 Setup screen, select ETCO2 upper or lower limit with the Item

key.

The arrow in the ETCO2 bar graph indicates the current ETCO

2 value.


Item Range Step Default setting

ETCO2

mmHgUpper 2 to 99, OFF 1 50


kPaUpper 1.0 to 13.5, OFF 0.5 7.0

Lower OFF, 0.5 to 13.0 0.5 3.0

NOTE

If you increase the upper limit over 99 (mmHg) or 13.5 (kPa), the

upper limit becomes OFF. If you decrease the lower limit below 1

(mmHg) or 0.5 (kPa), the lower limit becomes OFF.

6

6-4




6. MONITORING

Changing the Respiration Rate Alarm Limits

Set the upper and lower limit for the respiration rate alarm.

CAUTION



1. On the CO2 Setup screen, select respiration rate upper or lower limit with the

Item key.

The arrow in the RR bar graph indicates the current respiration rate.



RR

(count/min)

Upper 2 to 150, OFF 2 OFF

Lower OFF, 0 to 148 2 OFF

NOTE






6-4. CO2 MONITORING

Changing the APNEA Alarm Limit

Set the period of no respiration for the APNEA alarm. When the debrillator

cannot detect patient respiration for more than the selected seconds, the APNEA

alarm occurs.

CAUTIONWhen the alarm limit is set to OFF, there will be no alarm for that


1. On the CO2 Setup screen, select APNEA with the Item key.

2. Select apnea alarm limit with the ↓ or ↑ key.


APNEA (s) Upper 5 to 40, OFF 5 OFF

NOTE


6

6-4




6. MONITORING

Inspection of Measuring Accuracy

Daily Inspection of Measuring Accuracy

Perform daily accuracy inspection using your own respiration.

Put the larger end of the airway adapter (side for connecting to the patient’s mask

and tracheal tube) into your mouth and after stabilizing breathing, breathe in

the same way as in the resting state at a rate of 5 seconds per breath (12 breaths/

minute). Breathing too quickly or taking deep breaths will disable standard

measurements.

The standard ETCO2 concentration is 40 mmHg (5.3 kPa). Check that the CO2

gas concentration display is from 35 to 45 mmHg (4.7 to 6.0 kPa).

Inspection of Measuring Accuracy (Precise Method)

Check the measurement accuracy whenever you suspect the debrillator is not

reading correctly. This procedure does not calibrate CO2 sensor. It only checks

the measurement accuracy. If the measurement accuracy is not appropriate,

contact your Nihon Kohden representative.

CAUTION

Only use the specified items.

CAUTION

Follow the CAUTION label on the CO2 gas

cylinder.

CAUTION

After the lifetime of the CO2 gas cylinder

expires, the measurement accuracy cannot be

guaranteed.

The following items are required.

• 5% CO2 calibration gas

Manufacturer: Nellcor Puritan Bennett or Scott Medical Products

Cylinder name: OD (1 L disposable cylinder)

Outlet connection: CGA 600

Gas volume: 25 L (Provides about 50 to 100 calibrations)

Gas component: 5% CO2, 21% O2, balance N2

Accuracy: ±0.03% absolute

Expiration: 3 years after the gas is packed in the cylinder

• Flow regulator PR-150 ow regulator (full scale 700 psi)

Manufacturer: VICTOR High Purity & Instrumentation

Delivery ow (ow rate): 0.5 L/min

Inlet connection: CGA 600

• Tube

Internal diameter: 4 mm




6-4. CO2 MONITORING

• Slip joint

Manufacturer: Portex

Specication: 100/252 4 mm

When using a CO2 gas cylinder and ow regulator other than the above, the

following specications must be met. Make sure that the outlet connection of the

gas cylinder and the inlet connection of the ow regulator t together.

• 5% CO2 calibration gas

Gas component: 5% CO2, 21% O2, balance N2

Accuracy: ±0.03% absolute

• Flow regulator

Delivery ow (ow rate): 0.5 L/min

Checking Procedure

1. Connect the ow regulator to the CO2 gas cylinder by rotating the ow

regulator clockwise. Connect them rmly.

2. Connect the CO2 sensor kit to the SpO2/CO2 connector on the debrillator.

3. Connect the airway adapter to the CO2 sensor so that the marks on the

airway adapter and CO2 sensor align.

4. After checking that the CO2 gas cylinder is connected properly, gently turn

the knob of the ow regulator counterclockwise about half a turn to start the

gas ow.

5. Connect the slip joint to the airway adapter. CO2 gas ows in the airway

adapter and the instCO2 on the screen should read 38 mmHg. (Expiration

phase, 38 mmHg CO2 gas)

6. Disconnect the slip joint from the airway adapter and shake the CO2 sensor

to remove CO2 gas from the airway adapter. Open air ows into the airway

adapter and instCO2 on the screen should be 0 mmHg. (Inspiration phase, no

CO2 gas)

Knob

Pressuregauge

Pressuregauge

Slip jointKnob

Connect/disconnect

the airway adapter

repeatedly.

6

6-4




6. MONITORING

CAUTION

This method assumes that no CO2 gas is present in the inspiration

phase of breathing. Therefore, step 6 has to be performed to

simulate the inspiration phase of breathing so that the defibrillator

can correctly determine the CO2 concentration. The defibrillator

determines the CO2 concentration by comparing the change inCO2 concentration in the airway adapter during the inspiration and

expiration phase of breathing.

CAUTION

The defibrillator calculates the CO2 concentration by assuming

that the gas temperature is 37°C and the surrounding pressure

is 1 atmospheric pressure. Therefore, if this checking procedure

is performed at room temperature or lower, the defibrillator will

display higher instCO2 (there will be –0.4% per °C difference).Correspondingly, if the checking procedure is performed at high

altitude, the defibrillator will display a lower instCO2 reading (there

will be 1 mmHg/30 hPa difference).

7. Repeat steps 5 and 6 a few times and compare the readings of step 5. The

readings should be the same.

8. After checking, gently turn the ow regulator knob clockwise to stop the gas

ow.

NOTE

When the pressure gauge of the flow regulator reads 0, replace the

CO2 gas cylinder with a new one.




7

Section 7 Alarm Function

General ................................................................................................................................................................7.2

Alarm Types ............................................................................................................................................... 7.2

Alarm Indication ........................................................................................................................................7.2

Alarm List ..................................................................................................................................................7.3

Alarm Status Marks and Messages ......................................................................................................... 7.4

Temporarily Silencing an Alarm After It Occurs ...................................................................................................7.5

Silencing Alarms .......................................................................................................................................7.5

Resuming Alarms ......................................................................................................................................7.5

Suspending an Alarm Before It Occurs ...............................................................................................................7.6

Suspending Alarms ...................................................................................................................................7.6Automatic Alarm Recording .................................................................................................................................7.6

Setting Alarms .....................................................................................................................................................7.7

Alarm Setting Range .................................................................................................................................7.7

Setting Alarm Settings on the Alarm Setup Screen ..................................................................................7.8

Setting Alarm Settings on the Alarm Setup Screen of the Setup Screen .................................................. 7.9

Setting Alarms Individually ......................................................................................................................7.10




7. ALARM FUNCTION

General

Alarms let you know abnormalities of measurement environment, instrument and

measurement value of each parameter by messages on the screen and sound.

Alarm Types

Alarms are categorized into three types.

Alarm Description

Instrument alarm Generated when any instrument abnormality is

detected. (for example, discharged battery or out of

recording paper)

Alarm for measurement

environment

Generated when any abnormality is detected in

measurement environment. (for example, connector

off, check electrode, check probe, etc)

Vital alarm Generated when each measurement value exceeds

previously set upper/lower limits.

Alarm Indication

When an alarm occurs,

• An alarm sounds.

• An alarm message appears on the screen. For a vital alarm, the measurement

value is highlighted.

• Automatic alarm recording starts. (Only for vital alarms and only when the

alarm recording is set to ON.)

You can turn the alarm recording ON or OFF on the System Setup -

Conguration screen. Refer to Section 3 “System Setup Screen and Setup

Screen”.



7


7. ALARM FUNCTION

Alarm List

Type Alarm Alarm Display Alarm Sound

Instrument

Alarm (1)

SpO2 probe not working

Displayed during

detection

Continuous tone

SpO2 module not working

CO2 adapter abnormality

CO2 sensor not working

CO2 module not working

Overheating

High voltage monitor error

Relay drive error

Insert battery

Power abnormality

Charge battery (blinking 0 )

Replace battery

FET error

ERROR K×××

ERROR P×××ERROR D×××

ERROR C×××

ERROR A×××

Set energy to 50 J or less Continuous or beeping tone*

Instrument

Alarm (2)

Battery discharged (battery remaining charge is

1/3 )Displayed during

detectionContinuous or beeping tone*

Charge battery ( 1 3 )

INTERNAL DISCHARGE

Displayed for 5 seconds For 5 seconds

Out of paper

No report data

Low impedance

High impedance

Time to replace batteryDisplayed during

detection No alarm sound

Alarms for

measurement

environment

Pacing stopped (paddle disconnected)**

Displayed during

detection

Continuous tonePacing stopped (ECG lead disconnected) **

Change disposable pads

Continuous or beeping tone*Check disposable pads

Connect paddle

Use disposable pads Displayed for 5 secondsFor 5 seconds

Select ECG lead

Displayed during

detection

Select a different lead

Continuous or beeping tone*

Change ECG electrodes

Check ECG electrodes

SpO2 measurement unstable

Searching for SpO2 pulse

Check SpO2 probe site

Check SpO2 unit

SpO2 module disconnected**Continuous tone

CO2 module disconnected**

Connect AC power or Charge battery Continuous or beeping tone*

* You can select either continuous or beeping sound on the System Setup screen. Continuous: continuous beeping, Beeping (default setting): sounds for 3 seconds every 30 seconds

** You can silence alarm sound by pressing the Silence alarms key.




7. ALARM FUNCTION

Type Alarm Alarm Display Alarm Sound

Vital alarm

HR alarm

Highlighted value

Continuous or beeping tone

PR alarm

SpO2 alarm

etCO2 alarm

RR alarm

VF/VT alarm (Check Patient) Displayed duringdetectionAPNEA

Alarm Status Marks and Messages

Alarm off mark:

• Displayed at every parameter for which the upper and/or lower alarm limit is

set to OFF.

• Displayed at a parameter whose alarm is silenced.

• Displayed at every parameter when all alarms are suspended.

Value:

Highlighted while the value exceeds the alarm limit.

“Alarm off” message:

• Displayed at the top of the screen when any vital alarm upper/lower limit is set

to OFF.

• When the “Alarm silenced 2 min”, “Alarm silenced 1 min”, “Alarms

suspended 2 min” or “Alarms suspended 1 min” message is displayed, the

“Alarm off” message is not displayed. When the alarm silence or suspensionnishes, it is displayed again.

• Disappears when all alarm settings are set to settings other than OFF.

VF/VT alarm off mark:

• Displayed at the upper right corner of the screen.

• Displayed when VF/VT analysis is not performed.

• Displayed when “VF/VT Alarm” is set to “OFF” in Alarm Setup screen.

• Displayed when the paddle lead is selected and the external paddles or internal

paddles are connected.

• Displayed when the Setup screen, pacing screen, Basic checks screen or Alarm

Setup screen is selected.



7


7. ALARM FUNCTION

Temporarily Silencing an Alarm After It Occurs

When an alarm occurs, you can silence the alarm sound for two minutes.

NOTEAlarms which indicate instrument abnormalities* are not silenced by

pressing the Silence alarms key.

• When the following alarms occur, contact your Nihon Kohden

representative.

SpO2 probe not working Power abnormality

SpO2 module not working FET error

CO2 adapter abnormality ERROR K×××

CO2 sensor not working ERROR P×××

CO2 module not working ERROR D×××

Overheating ERROR C×××

High voltage monitor error ERROR A×××

Relay drive error

• When the following alarms occur, take a remedial action immediately,

referring to “Messages” in Section 9.

Insert battery

Charge battery (blinking 0 mark)

Replace battery

During alarm silence,

• the alarm sound is silenced.

• the “Alarm silenced 2 min” or “Alarm silenced 1 min” message is displayed at

the top of the screen.

When the alarm cause is removed during alarm silence, the alarm is cleared.

Silencing Alarms Press the Silence alarms key on the front panel.

Resuming Alarms

Alarms resume when:

• The cause of alarm continues after the alarm silence ends.

• The Silence alarms key is pressed during alarm silence.

• A different alarm (except for instrument alarm (2)) occurs.• The cause of alarm disappears during alarm silence, then the same alarm

occurs again.

* Instrument Alarm (1) on the page 7.3




7. ALARM FUNCTION

Suspending an Alarm Before It Occurs

An alarm can also be suspended before it occurs, for example, before you replace

the electrodes. The alarm suspend time is two minutes.

During alarm suspension, all alarms are suspended and

• the alarm sound is silenced.

• the “Alarms suspended 2 min” or “Alarms suspended 1 min” message is

displayed.

Suspending Alarms

Press the Silence alarms key on the front panel when no alarms are occurring.

WARNING

During alarm suspension (“Alarm off” or “Alarm suspended”

message displayed), all current alarms except for instrument alarm

group 1 are turned off. Be careful when you suspend the alarm.

Automatic Alarm Recording

When automatic alarm recording is set to ON, waveforms beginning 4 seconds

before and ending 8 seconds after the alarm are automatically recorded when an

alarm is generated. For details, refer to Section 8 “Recording”.



7


7. ALARM FUNCTION

Setting Alarms

Vital alarm limits can be set in three different ways:

• Set on the Alarm Setup screen while monitoring.

• Set on the Alarm Setup screen of Setup screen.

• Set on each setting screen for the individual parameter of the Setup screen.

When you change an alarm setting on one screen, the same setting on another

screen is also automatically changed.

CAUTION



Alarm Setting Range

NOTE

If you set a value higher than maximum value or lower than minimum

value, the alarm becomes OFF.

For example,

HR upper/lower limit

Upper: 290 → 295 → 300 → OFF

Lower: 25 → 20 → 15 → OFF

Item Range StepDefaultSetting

HR

(heart rate) beat/min

Upper 20 to 300, OFF 5 140


PR beat/minUpper 20 to 300, OFF 5 140


SpO2 %Upper 51 to 100, OFF 1 OFF


ETCO2

mmHgUpper 2 to 99, OFF 1 50


kPaUpper 1.0 to 13.5, OFF 0.5 7.0

Lower OFF, 0.5 to 13.0 0.5 3.0

RR count/minUpper 2 to 150, OFF 2 OFF

Lower OFF, 0 to 148 2 OFF

APNEA s Upper 5 to 40, OFF 5 OFF




7. ALARM FUNCTION

Setting Alarm Settings on the Alarm Setup Screen

NOTE

You can change alarm settings on the Alarm Setup screen only in the

MONITOR mode.

All vital alarms can be set on one screen. This way is useful when you are

monitoring a patient and you want to change or conrm the vital alarm settings.

1. Press the Multi-function key (Alarm Setup) on the front panel to display the

Alarm Setup screen.

2. Press the Item key to select the parameter. The left column is upper limits

and right column is lower limits. When the key is pressed and held, selected

items switch automatically.

3. Press the ↓ or ↑ key to set the upper and/or lower limit for the selected

parameter. When the key is pressed and held, the value increases or

decreases automatically.

NOTE

• If you set a value higher than the maximum value or lower than the

minimum value, the alarm becomes OFF.

• If you set the lower limit to a value higher than the upper limit,

the higher limit automatically increases. If you set the higher limit

to a value lower than the lower limit, the lower limit automaticallydecreases. The increased upper limit or decreased lower limit does

not become OFF.

4. Press the Monitor key to return to the monitoring screen.



7


7. ALARM FUNCTION

Setting Alarm Settings on the Alarm Setup Screen of the Setup Screen

All vital alarms can be set on one screen.



2. Select “Alarm Setup” with the Item ↓ or Item ↑ key and press the SET key.

The Alarm Setup screen appears.

3. Press the Item key to select the parameter. When the key is pressed and held,

selected items switch automatically.

4. Press the ↓ or ↑ key to set the upper and/or lower limit for the selected

parameter. When the key is pressed and held, the value increases ordecreases automatically.

NOTE





to a value lower than the lower limit, the lower limit automatically

decreases. The increased upper limit or decreased lower limit does

not become OFF.

5. Turn the Energy/Mode Select control to the MONITOR position.




7. ALARM FUNCTION

Setting Alarms Individually

You can set each vital alarm on each parameter setup screen.

Example: Setting the ECG alarm



2. Select “ECG Setup” with the Item ↓ or Item ↑ key and press SET key. The

ECG Setup screen appears.

3. Select “HR” with the Item key. When the key is pressed and held, selected

items switch automatically.

4. Select the heart rate upper and/or lower limit with the ↓ or ↑ key. When the

key is pressed and held, the value increases or decreases automatically.

NOTE





to a value lower than the lower limit, the lower limit automatically

decreases. The increased upper limit or decreased lower limit doesnot become OFF.

5. Turn the Energy/Mode Select control to the MONITOR position.




8

Section 8 Recording

About Recording ..................................................................................................................................................8.2

Changing Report and Recorder Settings ............................................................................................................8.4

Manual Recording ...............................................................................................................................................8.5

Real Time or Delayed Waveform Recording ..............................................................................................8.5

Procedure........................................................................................................................................8.5

Report Recording ......................................................................................................................................8.6

Periodic List Report Recording .......................................................................................................8.6

Alarm Report Recording .................................................................................................................8.6

Event List Report Recording ...........................................................................................................8.7

Defibrillation Report Recording .......................................................................................................8.9VF Analysis Report Recording ......................................................................................................8.10

Trend Report Recording ................................................................................................................ 8.11

Event Recording ......................................................................................................................................8.12

Saving the Administered Medication .......................................................................................................8.13

Automatic Recording .........................................................................................................................................8.14

Charging Recording (Auto Recording when Charging Starts After Discharge) ....................................... 8.14

Alarm Recording .....................................................................................................................................8.15

Periodic Recording ..................................................................................................................................8.16

Printed Letters and Marks .................................................................................................................................8.17




8. RECORDING

About Recording

Available recording types are shown on the next page.

NOTE• When the screen changes to any setup screen during recording,

recording automatically stops. Record again after you exit the setup

screen.

• When using a delivery checker to input ECG to the defibrillator, the

ECG polarity depends on the delivery checker model and connection of

the pads/paddles. For details on a delivery checker, refer to the manual

of the delivery checker.

For the recording examples in this section, “Printing character size” is set to

“Small” in the System Setup - Conguration screen.



8


8. RECORDING

Recording Mode Recorded DataLength/Capacity of

Recorded DataStart/Stop Operation

Manual

recording

(Real time or delayed)

Waveform recording

Waveform on the screen

Either real time or 4 seconds

delayed waveform recording

can be selected. (Delayed is

the default setting.)

Continuous Press the Record key. To

stop during recording,

press the Record key.

Reportrecording

Periodic List Periodic measurement data Up to 120 measurement

data

The periodic

measurement interval

can be selected on the

Recorder Setup screen.

Press the Record key

when the Report Setup

screen is displayed. To



Alarm ECG waveforms and another

parameter waveform when an

alarm occurs or the Event key

is pressed.

Waveforms for up to

60 alarms*

(when ECG is selected

at “RecWave” on the

Recorder Setup screen)

Event list Event list Up to 130 events

Deb Waveform at discharge and

settings

Up to 44 discharges*

Waveform from

10 seconds before to

12 seconds after

discharge

VF Analysis Waveforms of 6 seconds after

the CHARGE/AED button is

pressed and the analysis result

Up to 124 analyses*

Trend Trend graph and numeric data 1, 2, 4, 8 or 24 hours.

You can set the recorded

period at “Trend Time”

on the Report Setup

screen.

Event recording** ECG waveform when the

Event key is pressed.

Waveform from

4 seconds before to

8 seconds after the

Event key is pressed.

Press the Event key. To



Automatic

recording

Record on charging after

discharge***

ECG waveform before and

after discharge

ECG from the start

of energy charging to

6 or 12 seconds after

discharge

Starts when the

debrillator starts

charging energy.

To stop during recording,


Alarm recording** ECG waveform when an

alarm occurs

ECG waveform from

4 seconds before to

8 seconds after alarm

occurrence.

Starts automatically. To

stop recording, press the

Record key.

Periodic recording Periodic ECG, SpO2 and CO2

delayed waveforms

For 12 seconds

The recording interval

is set at “PeriodicRec”

on the Recorder Setup

screen.

Starts automatically. To

stop recording, press the

Record key.

* The Alarm, Deb and VF Analysis reports share memory. The length/capacity of recorded data is shown for one report

type when no data for the other two report types is saved in memory. If data of more than one report types is saved in

memory, the maximum length/capacity of recorded data for each report type decreases.

** This data is used for Alarm report recording.

*** This data is used for Deb report recording.




8. RECORDING

Changing Report and Recorder Settings

1. Turn the Energy/Mode Select control to the SETUP position to display the

Setup Menu screen.

2. Select “Report Setup” or “Recorder Setup” with the Item ↓ or Item ↑ key

and press the SET key. The Report Setup screen or Recorder Setup screen

appears.

Report Setup screen Recorder Setup screen

3. Select the item with the Item key.

Report Setup screen Report: Select the type of report recording from Periodic list,

Alarm, Event list, Deb, VF analysis and Trend.

Trend Time: Select the time length to be recorded in the Trend report

from 1, 2, 4, 8 and 24 hours.

List Interval: Select the measurement interval for Periodic List report

from 1, 5, 15, 30 and 60 min.

Delete Report?: Select Yes to delete all report data saved in the debrillator.

When Yes is selected, further conrmation keys appear.

Press the key for “Delete” to delete all report data.

Recorder Setup screen

PeriodicRec: Select the recording interval for the automatic periodic

recording from OFF, FREE, 15 min, 30 min, 60 min and

2 hrs. When FREE is selected, recording is performed at the

interval set on the “Periodic recording interval (min)” on

the System Setup - Conguration screen.

RecWave: Select the parameter(s) which is recorded in Waveform

recording, Alarm report recording, Event recording, Record

on charging after discharge, Alarm recording and Periodic

recording from ECG, ECG + SpO2 and ECG + CO2.

4. Select the setting value with the ↓ or ↑ key.




8


8. RECORDING

Manual Recording

Real Time or Delayed Waveform Recording

The ECG waveforms can be manually recorded at any time. You can record any

length waveform with this mode. Besides ECG waveforms, ID, date, time, ECG

lead and ECG sensitivity are also recorded. ECG waveform recordings are either

real time or delayed; you can select this on the System Setup - Conguration

screen. When Delayed recording is set to ON, the waveform from 4 seconds

before the Record key is pressed is recorded.

Procedure

To start recording, press the Record key. During recording, the Recording

mark appears on the screen. To stop recording, press the Record key again.

Recording example

CO2 and SpO2 are measured.

Delayed waveform recording

MONITOR mode

Time constant 0.32 s

AC filter is ON

ECG lead II

Paper speed 25mm/s

SpO2 sensitivity ×1

ECG sensitivity ×1




8. RECORDING

Report RecordingThere are six kinds of report recording: Periodic list, Alarm, Event list, Deb, VF

analysis and Trend. To print reports, you need to display the Report Setup screen.

Set the following settings on the Report Setup screen.

Periodic List Report Recording

Measurement values for each parameter at the selected interval are recorded in alist format.

Procedure

1. Select “Periodic list” at the Report on the Report Setup screen. Refer to

“Changing Report and Recorder Settings” in this section.

2. Press the Record key. The Report recording mark appears on the screen.

The recording stops when all data are recorded.

To stop recording, press the Record key again.

You can select the measurement interval at List Interval on the Report Setup

screen. The data for the Periodic list report recording remains in memory after

the power off.

Alarm Report Recording

ECG waveform and either SpO2 or CO2 waveform when the Event key is pressed

or when an alarm occurs is recorded. The recorded data are the same as that of

the Event recording and automatic alarm recording.

Procedure

1. Select “Alarm” at the Report on the Report Setup screen. Refer to “Changing

Report and Recorder Settings” in this section.



To stop during recording, press the Record key again.

The data for the Alarm report recording remains in memory after the power off.

• Waveforms for up to 60 alarms are saved when ECG is selected at RecWave

on the Recorder Setup screen. After waveforms for 60 alarms are saved, when

another alarm occurs, the waveform for that alarm is saved and the oldest 15

waveforms are deleted.

• Waveforms for up to 48 alarms are saved when ECG and SpO2 are selected at

RecWave on the Recorder Setup screen. After waveforms for 48 alarms are

saved, when another alarm occurs, the waveform for that alarm is saved and

the oldest 12 waveforms are deleted.

• Waveforms for up to 56 alarms are saved when ECG and CO2 are selected at

RecWave on the Recorder Setup screen. After waveforms for 56 alarms are

saved, when another alarm occurs, the waveform for that alarm is saved andthe oldest 14 waveforms are deleted.



8


8. RECORDING

Recording examples

• When the Event key is pressed

• When an alarm occurs

Event List Report Recording

The list of debrillator usage history with clock time is recorded in a

chronological order. This is useful for an operation diary or debrillator

operation history.

Procedure

1. Select “Event list” at the Report on the Report Setup screen. Refer to





The data for the Event list report recording remains in memory after the power is

turned off.

Recording example

Up to 10 events are recorded on one column. Up to 130 events are recorded.

After 130 event data are saved, when the debrillator detects another event, the

oldest data is deleted.




8. RECORDING

Recorded Events

Event Meaning

Power ON The power is turned on.

Power OFF The power is turned off.

Charging Charging for discharge is started.

Charged Charging for discharge is completed.

Discharge XXX J Debrillation is performed at XXX J.

Sync XXX J Synchronized cardioversion is performed at XXX J.

VF analysis start CHARGE/AED button is pressed in AED mode.

Shockable The debrillator detected a shockable rhythm after the CHARGE/AED button

was pressed in AED mode.

No Shockable The debrillator did not detect a shockable rhythm after the CHARGE/AED

button was pressed in AED mode.

Check Patient The debrillator detects a shockable rhythm.

Disarm The energy discharges internally within 20 seconds after charging.

Alarm HR *XXX Heart rate alarm occurs at XXX bpm.

Alarm PR *XXX Pulse rate alarm occurs at XXX.Alarm SpO2 *XXX SpO2 alarm occurs at XXX.

Alarm RR *XXX Respiration rate alarm occurs at XXX.

Alarm etCO2 *XXX mmHg ETCO2 alarm occurs at XXX mmHg.

Alarm etCO2 *XXX kPa ETCO2 alarm occurs at XXX kPa.

Alarm Apnea *XXX s Apnea alarm occurs at XXX seconds.

Event The Event key is pressed.

ECG electrode off A disposable electrode is detached from the patient.

ECG electrode set A disposable electrode is attached to the patient.

Dispo pads off The pad adaptor is disconnected from the debrillator, or the disposable pad is

detached from the patient.

Dispo pads set The pad adaptor is connected to the debrillator, or the disposable pad isattached to the patient.

Fixed mode start

(XXXppm, XXXmA)

The Fixed pacing mode (pacing rate XXX pulse/min and pacing current is

XXX mA) is started.

Demand mode start

(XXXppm, XXXmA)

The Demand pacing mode (pacing rate XXX pulse/min and pacing current is

XXX mA) is started.

Pacer stop (XXXppm, XXXmA) Pacing (pacing rate XXX pulse/min and pacing current is XXX mA) is

stopped.

Alarm suspend The alarm is silenced or suspended.

SpO2 module off The SpO2 module is disconnected from the debrillator.

SpO2 module set The SpO2 module is connected to the debrillator.

CO2 module off The CO2 sensor kit is disconnected from the debrillator.CO2 module set The CO2 sensor kit is connected to the debrillator.

Adrenaline The Medication key - Adrenaline is pressed.

Atropine The Medication key - Atropine is pressed.

Lidocaine The Medication key - Lidocaine is pressed.

Other The Medication key - Other is pressed.



8


8. RECORDING

Defibrillation Report Recording

Waveform at debrillation and cardioversion and discharge information are

recorded.

Procedure

1. Select “Deb” in “Report” on the Report Setup screen. Refer to “Changing





The data for the Debrillation report recording remains in memory after the

power off.

Recording example

Compressed ECG waveform is recorded in three rows. The amplitude of the

recorded waveform is 1/2 of the waveform on the screen (on screen: 10 mm/1mV

→ 5 mm/1mV).

Waveform of 22 seconds (10 seconds before and 12 seconds after discharge)

and setting at the discharge are recorded for one discharge. Up to 44 discharges

are recorded. After 44 data are saved, when the debrillator detects another

discharge, the data for that discharge is saved and the oldest 11 data (both

waveform and setting at discharge) are deleted.

When another discharge is performed within 22 seconds after previous discharge,

the recording is extended for 12 seconds after the second discharge and is

counted as one recording. In this case, maximum recordable discharge is less

than 44.

Up to 6 discharge marks “ ” are recorded on one waveform.

Discharge information

Date: Date when debrillation or cardioversion is performed.

Time: Clock time when debrillation or cardioversion is performed.Set Energy: Selected energy value

TTR: Skin-paddle (pad) contact impedance




8. RECORDING

Delivered: Output energy value. When TTR is 15 Ω or less, or 255 Ω or

more, 0 J is printed.

Shock Times: Total counts after the debrillator power is turned on.

Manual: Debrillation (“Manual Sync” is for Synchronized cardioversion

and “AED” is for AED.)

TEST: Printed only when energy discharge test is performed.

OK: Test OK NG: Test NG

VF Analysis Report Recording

Waveforms of 6 seconds after the CHARGE/AED button is pressed and the

analysis result are recorded.

Procedure

1. Select “VF Analysis” in “Report” on the Report Setup screen. Refer to





The data of the VF Analysis report recording remains in memory when the

debrillator power is turned off.

Waveforms for up to 124 VF analyses are saved. After 124 waveforms are saved,

when the debrillator performs another VF analysis, the waveform for that VF

analysis is saved and the oldest 31 data are deleted.

Recording examples



8


8. RECORDING

Trend Report Recording

The trend graph and numeric data of heart rate, SpO2, PR, ETCO2 and RR which

are saved in memory are recorded.

Procedure

1. Select “Trend” in “Report” on the Report Setup screen. Refer to “Changing





The data of the Trend report recording remains in memory when the debrillator

power is turned off.

You can select recorded trend time from 1, 2, 4, 8, 24 hours at Trend period on

the Report Setup screen. The relation between recorded trend time and interval of

data acquisition is shown below.

Trend time (hours) 1 2 4 8 24

Data acquisition interval (minutes) 1 2 4 8 24

The maximum, minimum and average value in each data acquisition interval is

recorded.

The vertical axis scale changes according to the recorded data so that all data can

be recorded on the paper.

Recording examples

• Heart rate and SpO2

• Pulse rate and ETCO2




8. RECORDING

• Respiration rate

Event Recording

ECG waveform from 4 seconds before to 8 seconds after the Event key is

pressed is recorded.

• When an alarm occurs, the Recording mark appears on the screen and

automatic alarm recording starts. The waveform from 4 seconds before to 12

seconds after the alarm occurrence is recorded.

• When energy charging starts, the Recording mark appears on the screen and

record on charging after discharge starts instead of event recording.

• If there is no paper in the recorder when the Event key is pressed, ECG

waveform at the time is saved as the data for alarm report recording.

Recording example



8


8. RECORDING

Saving the Administered Medication

When “Medication” on the System Setup - Conguration screen is set to ON

(Default setting: OFF), the administered medication (adrenalin, atropine,

lidocaine and other) can be saved and recorded as the event list report and alarm

report with the 12 seconds of ECG waveforms.

1. Set “Medication” on the System Setup - Conguration screen to ON.

Refer to “System Setup Screen” in Section 3.

2. Press the Event key. The Event recording starts. The function keys change to

Adrenalin, Atropine, Lidocaine and Other function keys.

3. Press the key for the administered medication. The function keys return to

the normal function keys 5 seconds after the Event key is pressed.

4. Set “Medication” on the System Setup - Conguration screen to OFF.

• Medications are not saved as sound data.

• During alarm recording, if two or more medication keys are pressed, only the

latest medication is saved as the event report and alarm report.




8. RECORDING

Automatic Recording

Charging Recording (Auto Recording when Charging Starts After Discharge)

NOTE

To perform record on charging after discharge, set “Record on chargingafter discharge” to ON on the System Setup - Configuration screen before

using the defibrillator.

The recording starts automatically when energy charging starts. During automatic

recording, the Recording mark appears on the screen. ECG waveform from

the start of charging to 12 or 6 seconds after discharge is recorded. When the

energy is externally discharged, information of the discharge is also recorded. To

stop during recording, press the Record key.

• If energy is not discharged within 40 seconds after charging is completed,

recording automatically stops.

• If the debrillator starts charging during Event recording or another type of

automatic recording, the current recording stops and the charging recording

starts.

• If another debrillation or cardioversion is performed while record on charging

after discharge is being performed, recording is extended for 12 seconds after

the second debrillation or cardioversion is performed.

Recording example



8


8. RECORDING

Alarm Recording

NOTE

To perform automatic alarm recording, set “Alarm recording” to ON on the

System Setup - Configuration screen before using the defibrillator.

Recording starts at the alarm occurrence. During alarm recording, the

Recording mark appears on the screen. The ECG waveform from 4 seconds

before to 8 seconds after the alarm occurrence is recorded. The waveform is

saved for the data of alarm report recording.

• When an alarm occurs during another recording, the currently performed

recording has priority.

• When energy charging starts during automatic alarm recording, the alarm

recording stops and the charging recording starts. (Only when “Record on

charging after discharge” is set to ON (6 s) or ON (12 s) on the System Setup -

Conguration screen before using the debrillator.)

Recording example




8. RECORDING

Periodic Recording

Recording automatically starts at a preset interval. 12 seconds of the

waveform(s) selected at RecWave on the Recorder Setup screen is recorded.

Besides ECG waveforms, ID, date, time, ECG lead and ECG sensitivity are also

recorded. Only delayed ECG waveform is recorded.

For recording interval, Select either 15 min, 30 min, 60 min, 2 hr or FREE at

PeriodicRec on the Recorder Setup screen.

When OFF is selected, automatic periodic recording is not performed.

When FREE is selected, recording is performed at the interval set on the

“Periodic recording interval (min)” on the System Setup - Conguration screen.

Recording example



8


8. RECORDING

Printed Letters and Marks

Item Printed Letters Description

Recording type

Event Report Event report recording

Deb Report Debrillation report recordingTrend Report Trend report recording

List Report List report recording

Alarm Report Alarm report recording

VF Report VF analysis report recording

Real time/Delayed recording*1Real Real time waveform recording

Delay Delayed waveform recording

Operation mode

Mon Monitoring mode

Manual Deb Manual debrillation mode

AED AED mode

Fix Pace Fixed Pacing mode

Demand Pace Demand Pacing Mode

Date*1

YYYY/MM/DD Year/Month/Day

MMM/DD/YYYY Month/Day/Year

YYYY/MMM/DD Year/Month/Day

DD/MM/YYYY Day/Month/Year

Clock time*2 XX:XX:XX Hour:Minute:Second

Instrument ID*1 ID: XXXXX

ECG sensitivity ×1/4, ×1/2, ×1, ×2, ×4, AUTO×1/4, AUTO×1/2, AUTO×1, AUTO×2, AUTO×4

Paper speed*150 mm/s

25 mm/s

ECG lead PADDLE, I, II, III, aVR, aVL, aVF, V, AUX, TESTSpO2 sensitivity*2 SpO2: ×8, ×4, ×2, ×1, ×1/2, ×1/4, ×1/8, AUTO

CO2 scale*1, *2 0-40 mmHg, 0-80 mmHg, 0-5.3kPa, 0-10.7kPa

AC lter*2AC Filter: ON AC lter ON

AC Filter: OFF AC lter OFF

Time constant*2T.C.: 0.32s 0.32 seconds

T.C.: 3.2 s 3.2 seconds

Heart rate*3 HR: XX

SpO2*3 SpO2: XX%

Pulse rate*3 PR: XX

Respiration rate*3 RR: XX

ETCO2*3 etCO2: XX mmHg, XX kPa

The point of discharge

Selected energy Set: XXX J

Shock times Shock Times: XX

TTR TTR: XXX ohm

Delivered energy Delivered: XXX J

Test discharge resultTest: OK Test discharge was performed normally.

Test: NG Test discharge failed.

Synchronization/non synchronization Sync/no display

Synchronization point

*1 The format can be set at System Setup screen.

*2 Can be set on the setup screen. Refer to Section 3.

*3 When an alarm occurs, the “*” mark is displayed before each value (example: HR:*200).




8. RECORDING

Item Printed letters Description

Pacing rate XX ppm

Pacing intensity XX mA

The point of pacing pulse output P

The point of event occurrence E

The point of implanted pacemaker pulse

output

Medication

Adrenalin Adrenalin was administered.

Atropine Atropine was administered.

Lidocaine Lidocaine was administered.

Other Other medication was administered.




9

Section 9 Messages and

Troubleshooting

Messages ............................................................................................................................................................9.3

Troubleshooting ...................................................................................................................................................9.9

General......................................................................................................................................................9.9

Defibrillation ............................................................................................................................................9.10

Pacing (TEC-5531 Only) .........................................................................................................................9.10

Monitoring ...............................................................................................................................................9.11

ECG ..............................................................................................................................................9.11

SpO2 .............................................................................................................................................9.12

CO2 ...............................................................................................................................................9.13

Recording ................................................................................................................................................9.14Battery .....................................................................................................................................................9.14

SD Card...................................................................................................................................................9.15




9. MESSAGES AND TROUBLESHOOTING

When trouble occurs, take quick action referring to this section. If there is any

damage or the debrillator or its peripheral component is suspected to be faulty,

turn the power off, attach a “Unusable” or “Repair request” label and contact




9



Messages

Message Description Action

AED AED mode is selected. —

Alarm off One or more alarms for parameters available

for measurement is set to OFF. —

Alarm silenced 1 min Alarm is silenced for 1 minute. —

Alarm silenced 2 min Alarm is silenced for 2 minutes. —

Alarms suspended All alarms are suspended. This message is

displayed only during basic checks. —

Alarms suspended 1 min Remaining time of alarm suspension is 1

minute. —

Alarms suspended 2 min When no alarm is occurring and the SILENCE

ALARMS key is pressed, this message is

displayed. Remaining time of alarm suspension

is 2 minutes.

—

Analyzing VF The debrillator is performing VF/VT analysis. —

APNEA Respiration was not detected for the period set

on the Alarm setup screen. —

Basic checks complete Basic checks are complete. —

Basic checks OK Basic checks are normally complete. —

Battery discharged Very little battery charge remains. —

Battery charge timed out Only displayed during battery test.

The battery was not fully charged 5 hours after

battery charging started.

—

Battery charging error Only displayed during battery test.

An error occurred in battery charging.

—

Battery discharge timed

out

Only displayed during battery test.

The voltage did not decrease to the specied

level 3 hours after battery discharging started.

—

Battery test complete Appears when battery test nishes. (when

charging for the next use is complete) —

Battery OK Battery test result is 70 to 100%. —

Battery WEAK Battery test result is 50 to 69%. —

Cannot use card An unspecied card is inserted.

— A card for version upgrade is inserted on the

Save Report screen.

Capacitor test fail Capacitor test failed. —

Capacitor test pass Capacitor test result is OK. —

Change disposable pads Deteriorated disposable pads (Abnormal

polarization voltage in PADDLE lead) —

Change ECG electrodes Deteriorated ECG electrodes (Abnormal

polarization voltage in ECG leads) —

Change to monitor mode The multi-function key was pressed in a mode

other than the MONITOR mode. —

CHARGED In manual or AED mode, high voltage energy

charging is complete. —

Charge battery There is little battery charge remaining. The0 mark is displayed.

—

CHARGING In manual or AED mode, the instrument isadjusting the energy in the capacitor. The

debrillator is charging high voltage energy.

—






Charging battery Only displayed during battery test.

The battery is being charged for the battery test. —

Check ECG electrodes An ECG electrode is detached from the patient. —

ECG connection cable or external ECG cable is

disconnected from the ECG connector. —

Check disposable pads In manual or AED mode, the contact impedanceof the disposable pads is over 350 Ω.

• Shave hair on the skin where pads are placed, then rmly attach the disposable

pads to the patient chest.

• Firmly connect the pad adapter and

disposable pads.

When PADDLE lead is selected, disposable

pads are not attached to the patient rmly.

The pad adapter is disconnected from the

disposable pads.

Firmly connect the pad adapter and

disposable pads.

In FIXED or DEMAND pacing mode, the

disposable pad is not rmly attached to the

patient.

Firmly attach the disposable pads to the

patient chest.

Check patient In background analysis, patient ECG was

judged as a shockable rhythm. —

Check pulse This message appears:• After third debrillation is performed in AED

mode

• When the debrillator did not detect a

shockable rhythm.

—

Check SpO2 probe site The probe attachment site is not appropriate. Attach the probe at a site indicated in the

probe operator’s manual.

The probe is deteriorated. Replace the probe with a new one.

Check SpO2 probe The probe is detached from the patient. Check the probe attachment condition and

remove the cause.

The probe is disconnected from the SpO2

adapter.

Securely connect the probe to the SpO2

adapter.

The probe expired. Replace the probe with a new one.

Checking battery Only displayed during battery test.

Battery capacity is being checked. —

Connect AC Power or

Charge Battery

In AED mode, the battery is discharged and the

energy for the debrillation cannot be charged.

Replace the battery or use AC power.

Connect external paddles

to paddle holders

Appears when performing basic checks and

the external paddles are not set on the paddle

holders.

—

Connect to AC power The debrillator is not connected to AC power

during battery test.

Connect the debrillator to AC power.

Connect paddle In FIXED or DEMAND pacing mode, the pad

adapter is not connected to the debrillator.

Connect the pad adapter to the debrillator

and then turn the Energy/Mode Selectcontrol to FIXED or DEMAND position.

In manual or AED mode, paddles or disposable

pads are not connected to the debrillator.

Connect the paddles or disposable pads to

the debrillator.

When PADDLE lead is selected, paddles

or disposable pads are not connected to the

debrillator.

Connect the paddles or disposable pads to

the debrillator.

CO2 adapter abnormality Insufcient light Refer to the operator’s manual of the CO2

sensor kit.

CO2 adapter is faulty or deteriorated. Replace the CO2 adapter with a new one.

CO2 sensor not working CO2 sensor is faulty or deteriorated. Replace the CO2 sensor with a new one.

CO2 module not working CO2 module is faulty. Contact your Nihon Kohden representative.



9




CO2 module disconnected CO2 cable is disconnected from the debrillator. You can make this message disappear by

pressing the Silence alarms key. Connect the

CO2 cable to the SpO2/CO2 connector. If the

message still appears, contact your Nihon


Debrillation necessary.

Check ECG.

By VF analysis with the CHARGE/AED

button, debrillation was judged to be

necessary.

—

Debrillation not

necessary. Check ECG.

By VF analysis with the CHARGE/AED

button, debrillation was judged to be

unnecessary.

—

Demand Demand pacing mode is selected. —

Discharging battery Only displayed during battery test.

The battery is being discharged for battery test. —

Did the alarm sound? The basic checks - Alarm check is being

performed. —

Did the recorder print? The basic checks - Recorder check is being

performed.

—

Enter password Password to enter manual mode is required. Enter a password.

Enter password again Entered password is not correct. Enter the correct password.

ERROR A××× Faulty HV Turn the Energy/Mode Select control to the

OFF position. Then turn on the debrillator

and do the same operation that you did

when the error message appeared.

If the error message still appears,

immediately turn off the power and contact


ERROR C××× Communication error

ERROR D××× Faulty ROM/RAM

ERROR K××× Faulty keys

ERROR P××× Faulty pacing unit

FET error The circuit to measure remaining battery charge

is faulty.

Contact your Nihon Kohden representative.

File Error Sound data saved in the SD card is damaged. —

Fixed FIXED pacing mode is selected. —

High impedance Skin-paddle contact impedance is too high. Press the paddles on the patient rmly.

High voltage monitor

error

Faulty high voltage unit Turn the Energy/Mode Select control to the

OFF position. Then turn on the debrillator

and do the same operation that you did

when the error message appeared.

If the error message still appears,

immediately turn off the power and contact


If no pulse, press

CHARGE/AED button

Appears 5 seconds after the conrmation

message after CPR is displayed. —

When not performing CPR, appears 5 seconds

after the message conrming pulse. —

If no pulse, start CPR When CPR time is set in AED mode, this

message appears after third debrillation. —

INTERNAL

DISCHARGE

Energy was not discharged to the patient. —

Insert ATA CARD You tried to save data in a memory card when

no card was inserted in the debrillator.

Insert a specied memory card into the

debrillator.

Insert battery You tried to do the battery test when the battery

was not inserted in the debrillator. —

Left side CO2 not

measured

A CO2 cable was connected to the left SpO2/

CO2 connector when a CO2 cable was alreadyconnected to the right SpO2/CO2 connector.

Only one CO2 can be measured. If two

CO2 cables are connected, only the rstconnected CO2 is measured. Disconnect one

of the CO2 cables.






Left side SpO2 not

measured

An SpO2 cable was connected to the left SpO2/

CO2 connector when an SpO2 cable was already

connected to the right SpO2/CO2 connector.

Only one SpO2 can be measured. If two

SpO2 cables are connected, only the rst

connected SpO2 is measured. Disconnect

one of the SpO2 cables.

Low impedance Skin-paddle contact impedance is too low. Check that the paddles do not touch each

other.

The “M” mark is

displayed beside the SpO2

value.

SpO2 measurement is unstable due to patient

body movement.

If this message appears frequently, check

the patient and probe attachment condition.

Reattach the probe to the patient if

necessary.

Manual debrillation? “Manual deb conrmation” is set to “conrm”

and the Energy/Mode select control is turned to

the position of debrillation.

—

No report data You cannot print report because there is no data

for report recording saved in the debrillator. —

Not enough free memory Very little free memory in the SD card —

Now pacing The debrillator is outputting pacing pulses. —

Now playing Sound is playing back. — Out of paper Out of recording paper Change the role of recording paper.

Recorder door is open. Press the magazine until it clicks.

Overheating Faulty high voltage unit Turn the Energy/Mode Select control to the

OFF position and leave the debrillator for

20 minutes. Then turn on the debrillator

and check if the message appears again.

If it still appears, immediately turn off the

power and contact your Nihon Kohden

representative.

The debrillator discharged too frequently and

the internal temperature is too high.

Pacing stopped (ECG lead

disconnected)

Pacing stopped because:

• An electrode lead is disconnected from an

electrode.• An electrode is detached from the patient.

• Electrode lead is disconnected from the

JC-762V connection cable.

• Bad contact between the electrode and lead

clip.

• Electrode lead discontinuity

• Abnormally high polarization voltage

• Firmly connect the electrode lead to the

ECG electrode.• Replace the electrodes with new ones.

• Firmly connect the electrode lead to the

connection cable.

• Replace the electrode lead with a new

one.

• Replace the electrode lead with a new

one.

• Replace the electrodes with new ones.

Pacing stopped (paddle

disconnected)

Pacing stopped because:

• The pad adapter is disconnected from the

disposable pads.

• The disposable pads are detached from the

patient.

• The skin-pad contact impedance is high.

• Firmly connect the pads to the pad

adapter. Firmly connect the pad adapter to

the paddle connector.• Attach the disposable pads to the patient.

• Firmly attach the disposable pads to the

patient.

Set the pacing current to 0 mA, then

increase the current gradually to set the

lowest effective pacing current.

If these actions do not solve the problem,

clean the skin and use new disposable

pads. Refer to Section 5.

Power abnormality Input power voltage is too high. —

Press CHARGE/AED button

When the “Check Pulse Pattern” on the SystemSetup screen is set to 3 (no checking pulse), in

AED mode, this message appears 5 seconds

after the “Check patient” message appears.

—

Press CHARGE button Appears as the guidance for capacitor test. —



9




Press DISCHARGE

buttons until discharge

Appears in discharge check. —

Relay drive error Faulty high voltage unit Contact your Nihon Kohden representative.

Replace battery Battery test result is 0 to 49%. The debrillator

judged that the battery should be replaced with

a new one.

—

Right side CO2 not

measured

A CO2 cable was connected to the right SpO2/

CO2 connector when a CO2 cable was already

connected to the left SpO2/CO2 connector.

Only one CO2 can be measured. If two

CO2 cables are connected, only the rst

connected CO2 is measured. Disconnect one

of the CO2 cables.Debrillator power is turned on when two CO2

cables are connected.

Right side SpO2 not

measured

A SpO2 cable was connected to the right SpO2/

CO2 connector when a SpO2 cable was already

connected to the left SpO2/CO2 connector.

Only one SpO2 can be measured. If two

SpO2 cables are connected, only the rst

connected SpO2 is measured. Disconnect

one of the SpO2 cables.Debrillator power is turned on when two SpO2

cables are connected.

SD: Insert a Card SD card is not inserted. Insert the SD card into the SD card slot.

SD: Card Error Could not access the SD card. —

SD: Ready The SD card is ready to use. —

SD: Accessing Accessing the SD card. —

Searching for SpO2 pulse The instrument is searching for correct pulse

waveform.

Wait until the pulse waveform is detected.

SpO2 value cannot be measured because of

unstable pulse waveform.

The probe is detached from the patient. Check the probe attachment and remove the

cause.

Select a different lead During pacing in DEMAND mode, ECG lead is

set to a lead other than ECG leads. —

Select ECG lead Under the setting that does not permitsynchronized cardioversion with PADDLE

lead, SYNC mode is selected with PADDLE

lead.

—

SYNC button is pressed when TEST lead is

selected. —

TEST lead is selected in pacing mode. —

Select AED or monitor if

not manual debrillation

When “Manual deb conrmation” is set to

“password” or “conrmation” and the Energy/

Mode Select control is turned to the position of

debrillation.

—

Set energy to 50 J or less Above 50 J is selected when the internal

paddles are connected to the debrillator. —

Set recording paper Recording paper is not set in the recorder

during basic checks.

Set the paper in the recorder.

Set to 200 J You cannot perform the HV capacitor test with

the energy set to other than 200 J.

Set the energy to 200 J.

Shutdown NOW The debrillator is shutting down now.

NOTEWhile the “Shutdown NOW” message isdisplayed on the screen, do not disconnectthe power cord from the defibrillator or ACoutlet and do not remove the battery packfrom the defibrillator. The internal data maybe damaged.

—

SpO2 module disconnected SpO2 cable is disconnected from the

debrillator.

Connect the SpO2 to the SpO2/CO2

connector. If the message still appears,

contact your Nihon Kohden representative.






SpO2 module not working Faulty SpO2 module Contact your Nihon Kohden representative.

SpO2 probe not working The probe lifetime is expired. Replace the probe with a new one.

Probe discontinuity or short-circuit Replace the probe with a new one.

Faulty cable of the SpO2 adapter Replace the SpO2 adapter with a new one.

Faulty SpO2 probe Replace the SpO2 probe with a new one. If

the message still appears, replace the SpO2 adapter.

Stand clear In AED mode, the CHARGE/AED button is

pressed and the debrillator starts VF analysis. —

Stand clear and press

DISCHARGE buttons

In AED mode, charging debrillation energy is

complete. —

Start CPR

This message appears:

• When CPR is required

• After discharge for one sequence

• When nonshockable rhythm is detected

—

SYNC Synchronized cardioversion is selected. —

Test fail Energy was not discharged properly in

discharge test. —

Test OK Energy was discharged properly in energy

discharge test. —

Testing. Please wait. The debrillator is performing the HV capacitor

test. —

Time to replace battery More than two years have passed since the key

for “Reset” was pressed. —

Use disposable pads In FIXED or DEMAND pacing mode,

disposable pads are not used. —

In AED mode, disposable pads are not used. —

Use another instrument ERROR A××× appeared in basic checks. —

Was the voice heard? The basic checks-voice check is being performed.

Conrm that the voice is heard.



9



Troubleshooting

General

Problem Possible Cause Action

The instrument heats up. The instrument is used for many hours. There is no abnormality in the

instrument.

Instrument abnormality Turn the Energy/Mode Select control

to OFF position and disconnect the

power cord. Contact your Nihon


No operation when the instrument is

turned on.

The power cord is disconnected. Firmly connect the power cord to the

AC outlet and the debrillator.

The battery is not installed. Install the specied battery.

Faulty battery Replace the battery with a new one

(NKB-301V).

Remaining battery charge is low. Charge the battery.Instrument abnormality Contact your Nihon Kohden

representative.

Screen is dim. Waveform and characters

are not seen.

Instrument abnormality Contact your Nihon Kohden

representative.

The printed date is JAN/01/80. The backup battery is almost discharged. Replace the backup battery with a

new one. For replacement, contact


(Under normal use condition, the

backup battery lifetime is about 6

years.)

The report data are not saved. Faulty internal memory Contact your Nihon Kohden

representative.

On the Setup screen, the report data

were deleted.

Deleted data cannot be recovered.

All settings set in the Setup screen and

System Setup screen return to the default

settings.

Faulty internal memory Contact your Nihon Kohden

representative.

When the battery is installed, the

instrument suddenly changes to battery

operation.

When the battery is not installed, the

instrument power suddenly drops.

Power voltage changed. Conrm the AC power cord

connection. When the power cord

is properly connected and it does

not solve the problem, contact your

Nihon Kohden representative.

The date and time printed on the

recording paper is incorrect. — Set the date and time on the Date/

Screen screen. Refer to Section 3.

The backup battery for the clock is

discharged.

Contact your Nihon Kohden

representative.

On the screen, there are some pixels

which have randomly abnormal color or

do not light.

For the TFT LCD screen, it is considered

normal if some pixels have randomly

abnormal color or do not light.

—

No sound is heard. “Voice prompt” is set to “OFF” in the

System Setup - Conguration screen.

Increase the volume.

Faulty speaker or speaker cable

discontinuity

Repair is necessary. Contact your






Defibrillation


The debrillator self-discharges the

energy during charging.

In battery operation, the battery is almost

discharged.

Operate the debrillator on AC

power and recharge the battery. The

battery is automatically charged

when the debrillator is connected to

AC power.Faulty high voltage unit

(An error code appears on the screen.)

When an error code appears on the

screen, use another instrument. The

instrument is faulty. Contact your


Cannot switch to synchronized mode. Appropriate lead is not selected. Change to the appropriate lead.

You tried to perform synchronized

cardioversion with the PADDLE lead

but synchronized cardioversion with

the PADDLE lead is set to OFF on the

Paddle Setup screen.

On the Paddle Setup screen, set the

“Sync by paddle lead” to ON.

“0 J” is printed on the debrillation

report recording.

TTR (transthoracic resistance) is 15 Ω

or less.

Check that the paddles do not touch

each other.TTR (transthoracic resistance) is 255 Ω

or more.

Press the paddles on the patient

rmly.

Pacing (TEC-5531 Only)


Although the PULSE lamp is lit, pacing

pulse does not appear on the ECG.

Pacing pulse is not output. Contact your Nihon Kohden

representative.

Although the START/STOP key is

pressed, pacing does not start.

Pacing energy is set to 0 mA. Set the appropriate pacing energy

with the PACING OUTPUT Up/Down key.

In DEMAND mode, selected pacing rate

is slower than the patient heart rate.

Set the pacing rate appropriate for

the patient heart rate. When the

patient heart rate is slower than the

selected pacing rate, pacing pulse is

output automatically.

Faulty pacing function

(A system error code appears on the

screen.)

Contact your Nihon Kohden

representative.

After starting pacing, the “Pacing

stopped (paddle disconnected)” message

appears and pacing stops.

Contact impedance between patient skin

and disposable pads is high.

• Firmly attach the disposable pads

to the patient.

• Set the pacing current to 0 mA,then increase the current gradually

to set the lowest effective pacing

current.

If these actions do not solve the

problem, clean the skin and use new

disposable pads. Refer to Section 5.



9



Monitoring

ECG


Dotted lines appear instead of the ECG

waveforms.

• An ECG electrode is detached.

• An electrode lead is disconnected

from the electrode.

• The ECG connection cable isdisconnected from the debrillator.

• An electrode lead is faulty.

Remove the cause. If it does not

solve the problem, change the lead.

Changing the lead does not solve

the problem, the instrument isfaulty. Contact your Nihon Kohden

representative.

Baseline drifting Patient body movement Check the patient.

AC interference

(50 or 60 Hz sine wave is superimposed

on the ECG waveform.)

On the Setup screen, AC hum lter is set

to off.

• On the Setup screen, set the AC

hum lter to on.

• Check if there is AC interference

with other instruments, and remove

the cause.

ECG waveform does not appear on the

screen although electrodes are connected

properly.

• Electrode lead discontinuity

• Dirty electrode

Replace the electrodes or leads with

new ones.

New and old or other types of electrodes

are used together.

Use the same type electrodes which

are purchased together.

No sync sound “QRS Volume” is set to “0” in the Setup

screen - QRS Setup.


“QRS Sound” is set to “SpO2” in the

Setup screen - QRS Setup.

Set “QRS Sound” to “ECG”.


discontinuity



QRS sync mark is not displayed. On the Setup screen, pacing pulse

rejection is set to ON and large

amplitude AC interference noise is on

the ECG waveform.

• Remove the cause of the noise.

• On the Setup screen, set the AC

hum lter to ON.

• On the Setup screen, set pacing

pulse rejection to OFF.Sync sound is irregular although there is

no arrhythmia.

Noise was misjudged to be QRS. Remove the cause of the noise.

No alarm is generated. The Silence alarms key is pressed. Press the Silence alarms key again.

On the Setup screen, alarm is set to OFF. On the Setup screen, set the upper/

lower limit of each vital alarm.

Faulty speaker Repair is necessary. Contact your






SpO2


SpO2 value is not displayed on the

screen.

The SpO2 adapter cable is disconnected

from the SpO2/CO2 connector.

Connect the SpO2 adapter to the

SpO2/CO2 connector.

The SpO2 probe is disconnected from the

SpO2 adapter.

Firmly connect the probe to the SpO2

adapter.

Cable discontinuity in SpO2 adapter or probe

Replace the SpO2 adapter or probe.

SpO2 probe attachment to the patient is

loose.

Firmly attach the probe to the

patient.

Dotted lines appear instead of the pulse

waveforms.

SpO2 probe attachment to the patient is

loose.

Firmly attach the probe to the

patient.

Faulty DSI or DSI/AUX out interface

unit or discontinuity



Pulse waveform is not displayed on the

screen.

SpO2 probe is disconnected from the

SpO2 adapter.

Connect the probe to the SpO2

adapter.

SpO2 adapter is disconnected from the

debrillator.

Connect the SpO2 adapter to the

debrillator.

Unstable SpO2 value Inappropriate probe size Use a probe appropriate for the

patient.

The probe is attached to the same limb

that is used for NIBP measurement or an

IBP catheter.

Attach the probe to the opposite

limb. Avoid sites where the blood

circulation changes greatly.

Using electrical surgery unit. Keep the SpO2 adapter cable and

probe cable away from an electrical

surgery unit. Wait until the pulse

waveform becomes stable.

Measuring at a site with venous pulse. Correct measurement cannot be

done.

Deformed or damaged SpO2 probe Probe was disinfected in a way otherthan the specied way.

Replace the probe with a newone. Use the specied disinfecting

method.

SpO2 probe is repeatedly used. Replace the probe with a new one

when its lifetime is over.

Sine noise on the pulse waveform Interference by external light Cover the probe attachment site to

block the light.

Correct AC line frequency is not set. Check the actual AC line frequency

and the AC line frequency settings.

No sync sound “QRS Volume” is set to “0” in the Setup

screen - QRS Setup.


“QRS Sound” is set to “ECG” in the

Setup screen - QRS Setup.

Set “QRS Sound” to “SpO2”.


discontinuity





9



CO2


The measured value is not displayed on

the screen.

The CO2 sensor kit cable is disconnected

from the SpO2/CO2 connector.

Connect the CO2 sensor kit cable to

the SpO2/CO2 connector.

CO2 gas is in the inspiration. With the CO2 sensor kit,

measurements are based on the

assumption of no CO2 gas in theinspiration. Do not connect a Jackson

Rees respiration circuit or Mapleson

D respiration circuit to the patient.

Measurement cannot be done

correctly.

The airway adapter is dirty. Replace the airway adapter with a

new one.

The measurement is preformed where

atmospheric pressure is low, such as at

high altitude.

Consider the atmospheric pressure

when making evaluations.

The measured value is high. N2O is mixed in the inspiration or when

high concentration of oxygen is inspired.

Remove the cause and measure

again.The measured value is inaccurate. Jackson Rees respiration circuit or

Mapleson D respiration circuit is

connected to the patient.

Cannot measure correctly. Do not

connect a Jackson Rees respiration

circuit or Mapleson D respiration

circuit to the patient.

The respiration rate of the patient is very

high.

Cannot measure correctly.

The respiration is irregular. Cannot measure correctly.

Oscillation Check the respirator and remove the

cause.

Doing suction with a suction catheter in

the airway adapter.

Do not let the suction catheter in the

airway adapter.

CO2 value does not change. The airway adapter is detached from the

patient.

Check the airway adapter

attachment.

The patient is in apnea. The previous value is displayed on

the screen until the next inspiration is

detected. Check patient ventilation.

The respiration waveform does not

appear.

Oscillation Check the respirator and remove the

cause.

The CO2 sensor is disconnected from the

respiration circuit.

Connect the CO2 sensor to the

respiration circuit.

The red LED on the CO2 adapter blinks. CO2 sensor or CO2 adapter is faulty. Replace the CO2 sensor or CO2

adapter with a new one.

The respiration has not been detected forlonger than 20 s.

The red LED blinks when therespiration has not been detected for

longer than 20 s regardless of the

alarm setting on the debrillator.





Recording


Printing is blurred. Dots are missing. The thermal head is dirty. • Clean the thermal head with Nihon

Kohden specied head cleaning

pen (option). If it does not solve

the problem, replace the thermal

head. Contact your Nihon Kohdenrepresentative.

• Perform the recorder Test on the

System Setup screen to check the

printing quality.

Nihon Kohden specied paper is not

used.

Use Nihon Kohden specied

recording paper.

Recording paper cannot be set correctly. Nihon Kohden specied paper is not

used.

Use Nihon Kohden specied

recording paper.

The slide plate is not located correctly. Locate the slide plate correctly. Refer

to “Loading the Recording Paper” in

Section 2.

Nothing is printed. The recording paper is not loaded. Load recording paper.Recording unit door is not properly

closed.

Close the door until it clicks.

The Recording lamp does not light. Press the Record key again. If

the lamp does not light when you

press the Record key, the key is

faulty. Contact your Nihon Kohden

representative.

The recording paper is set with the

wrong side facing up.

Set the recording paper correctly.

Paper skews to one side. The recording paper is not loaded

correctly.

Set the paper straight. Refer to

“Loading the Recording Paper” in

Section 2.

Printout is light. The recording unit temperature is too

hot.

Put the debrillator in a cooler place.

If this does not solve the problem,

the recording unit is faulty. Contact


Battery


The battery charging lamp is blinking. The debrillator is too hot. Bring the debrillator to a cool

place. When the battery temperaturedecreases, charging resumes.

After starting battery charging, the

charging stops. (Neither battery charging

lamp nor battery charge complete lamp

lights.)

Faulty battery Replace the battery with a new one.

Charging circuit is not working. Faulty charging circuit. Contact your


The “Replace battery” message appears. The battery is deteriorated. Replace the battery with a new one.



9



SD Card


Data cannot be saved in the memory

card.

A version upgrade card is inserted

instead of a memory card.

Insert a specied card.

The card is not inserted. Insert a specied card.

The card is not inserted properly. Firmly insert the card.

A card other than specied card is

inserted.

Insert a specied card.

Memory is full. Use a new card, or delete

unnecessary data.

The card is write-protected. Release the write-protect.

The card is not formatted. Format the card in the System Setup

- Conguration screen.




10

Section 10 Maintenance

Cleaning, Disinfecting and Sterilization .............................................................................................................10.2

Defibrillator ..............................................................................................................................................10.2

External Paddles .....................................................................................................................................10.2

Paddle Holders ........................................................................................................................................10.3

Internal Paddles ......................................................................................................................................10.3

Battery .....................................................................................................................................................10.4

ECG Electrode Leads, ECG Connection Cable and Pad Adapter ..........................................................10.4

Disposal and Replacement ................................................................................................................................ 10.5

Battery .....................................................................................................................................................10.5

Disposal of Battery Pack ...............................................................................................................10.5Replacing Battery Pack .................................................................................................................10.5

Disposable Pads......................................................................................................................................10.7

Lifetime .......................................................................................................................................... 10.7

Disposal ........................................................................................................................................10.7

Test Electrode Plates (On the Paddle Holders) .......................................................................................10.7

Lifetime .......................................................................................................................................... 10.7

ECG.........................................................................................................................................................10.7

Electrode Lifetime .........................................................................................................................10.7

Disposing of Electrodes ................................................................................................................10.7

SpO2 and CO2 ........................................................................................................................................10.7Check After Use ................................................................................................................................................10.8

Periodic Inspection ............................................................................................................................................10.9

Daily Inspection .......................................................................................................................................10.9

Monthly Inspection ..................................................................................................................................10.9

Checking External Paddles ...........................................................................................................10.9

Checking 270 J Energy Charge and Disarm ............................................................................... 10.10

Battery Test ................................................................................................................................. 10.11

Checking the Battery Appearance .............................................................................................. 10.13

HV Capacitor Test ....................................................................................................................... 10.14

Recorder Test .............................................................................................................................. 10.15

Date and Time Adjustment .......................................................................................................... 10.15

Yearly Inspection ................................................................................................................................... 10.15

Periodical Replacement Schedule ................................................................................................................... 10.16

Repair Parts Availability Policy ........................................................................................................................ 10.16

Storage ............................................................................................................................................................ 10.16

Defibrillator and Battery ......................................................................................................................... 10.16

Short Term Storage (Ready for Use at Any Time) ....................................................................... 10.16

Long Term Storage ...................................................................................................................... 10.17

Disposable Pads and ECG Electrodes .................................................................................................. 10.17




10. MAINTENANCE

Cleaning, Disinfecting and Sterilization

CAUTION

Before maintenance, cleaning or disinfection, turn the defibrillatorpower off, disconnect the power cord from the AC socket and

then remove the battery from the defibrillator. Failure to follow this

instruction may result in electrical shock and defibrillator malfunction.

For SpO2 adapter, SpO2 probe, CO2 sensor cable and CO2 sensor, refer to each

operator’s manual.

Defibrillator

CAUTION

Do not use the following chemicals to clean the defibrillator, pads

adapter or ECG connection cable. These chemicals melt or crack the

plastic surface.

Thinner, trichloroethylene, carbon tetrachloride, gasoline, benzine,

kerosene, benzene, toluene

Use a soft cloth moistened with water or disinfecting alcohol to wipe the dirtfrom the exterior surface of the debrillator. Then wipe them with a clean and

dry cloth.

External Paddles

CAUTION

Do not bend the connector pins of the external paddles. If pins are

bent, replace the paddle with a new one. With a bent pin, energy

cannot be discharged because of poor continuity.

CAUTION

The external paddles cannot be sterilized.

CAUTION

Do not heat the external paddles above 60°C (140°F) or put them in

liquid.

Use a soft cloth moistened with disinfecting alcohol to wipe the contact gel

(GELAID) from the electrodes and handles of the external paddles. Then wipe

them with a clean and dry cloth.



10


10. MAINTENANCE

Paddle Holders

CAUTION

Do not use the following chemicals to clean the defibrillator, pads

adapter or ECG connection cable. These chemicals melt or crack the

plastic surface.

Thinner, trichloroethylene, carbon tetrachloride, gasoline, benzine,

kerosene, benzene, toluene

CAUTION

Do not put gauze moistened with physiological saline solution on

the paddle holders. This may cause rusting or discoloration of the

electrode plate of the external paddle and test electrode (metal parts

of the paddle holders).

Use a soft cloth moistened with water or disinfecting alcohol to wipe the contact

gel (GELAID) from the paddle holders and the test electrode plates. Then wipe

them with a clean and dry cloth.

The test electrode plate on the paddle holder must be replaced periodically. Refer

to “Disposal and Replacement” later in this section.

Internal Paddles

CAUTION

Do not bend the connector pins of the internal paddles. If pins are

bent, replace the paddle with a new one. With a bent pin, energy

cannot be discharged because of poor continuity.

CAUTION

Replace an internal paddle with a new one after about 100 times

autoclaving because the internal paddles can withstand up to 100

times autoclaving under the following conditions. More autoclaving

may cause cable discontinuity and damage the cable surface.

CAUTION

Replace an internal paddle with a new one after about 100 times

EOG sterilization.

NOTE

The electrode and the handle cannot be separated.

Test electrode plate




10. MAINTENANCE

After use, clean and disinfect the internal paddles according to the accompanying

document of the internal paddles.

To remove the remaining gas from the paddles after sterilization, rst decrease

the internal pressure of the sterilization equipment to –760 mmHg with a vacuum

pump, then add carbon dioxide or antiseptic gas in the equipment. Repeat this

procedure (aeration) at least 5 times. Take the paddles out of the sterilization

equipment and do not use them for at least 20 days.

Autoclaving

Pressure: 2.0 kg/cm2 (196 kPa)

Temperature: 132°C (269.6°F)

Period: 10 minutes

Battery

Remove dirt from the battery every 6 months.

ECG Electrode Leads, ECG Connection Cable and Pad Adapter

Thoroughly wipe ECG electrode leads, an ECG connection cable and pad

adapter with a soft cloth moistened with water, neutral detergent or disinfecting

alcohol.

To disinfect, wipe it with a soft cloth moistened with any of the disinfectantslisted below. Use the recommended concentration.

Disinfectant Concentration (%)

Glutaraldehyde solution 2.0

Alkyldiaminoethylglycine hydrochloride 0.5

Benzalkonium chloride 0.2

Benzethonium chloride solution 0.2

Chlorhexidine gluconate solution 0.5



10


10. MAINTENANCE

Disposal and Replacement

Battery

Disposal of Battery Pack

NOTEThe battery is NiMH. Before disposing of the battery, check with your local

solid waste officials for details in your area for recycling options or proper

disposal. The battery is recyclable. At the end of its useful life, under

various state and local laws, it may be illegal to dispose of this battery

into the municipal waste stream. Before disposing of the defibrillator,

remove the battery from the defibrillator.

Replacing Battery Pack

Replace the battery pack with a new one within two years after the rst use.

Replacing the battery 18 months after the rst use is recommended.

NOTE

• Use only the NKB-301V rechargeable battery.

• Write down the battery replacement date on the battery before battery

replacement.

• Battery replacement must be performed only by service staff.

1. On the new battery, write the date when usage starts.

2. Conrm that the Energy/Mode Select control is set to OFF. Disconnect the power cord from the debrillator.

CAUTION

When inserting or removing the battery pack, disconnect the power

cord from the defibrillator. Otherwise, the operator may receive

electrical shock.

NOTE





3. Turn the knob on the battery holder cover counterclockwise and remove the

battery pack holder cover.




10. MAINTENANCE

4. Disconnect the battery cable by holding the battery cable connector and

remove the battery from the debrillator.

5. Insert the new battery into the battery pack holder.

6. Securely connect the battery connector to the connector inside the battery

pack holder until it clicks and locks.

7. Close the battery pack holder cover. Be careful not to pinch the cable. Secure

the battery pack holder cover by turning the knob clockwise.

8. On the battery check label, write the date when usage starts. Attach the label on the debrillator so that you can see them easily, for

example, on the upper part of the right side panel.

9. Reset the date of rst use of the battery.

i) Display the System Setup - Battery Test screen.

ii) Press the Reset key to reset the date of rst use of the battery. The “Time

to replace battery” message appears two years after the Reset key is

pressed.

NOTEYou must do this step when the battery is replaced. Otherwise, the

defibrillator does not display the “Time to replace battery” message to

prompt you to replace the battery.



10


10. MAINTENANCE

Disposable Pads

Lifetime

WARNING

• Replace pads after 1 hour pacing.

• Do not use after expiration date.

CAUTION

For long term ECG monitoring, replace pads every 24 hours.

Disposal

Follow your local laws for disposing of medical waste. To prevent second

infection, do not dispose of the disposable pads with other waste.

Test Electrode Plates (On the Paddle Holders)

Lifetime

Replace the test electrode plates every two years.

If the contact lamp on the external paddle lights in orange frequently even when

you clean and disinfect the external paddles and paddle holders properly and

make the skin-paddle contact impedance as low as possible, the test electrode

plates may be deteriorated. Contact your Nihon Kohden representative.

ECG

Electrode Lifetime

Replace the ECG disposable electrodes with new ones about every 24 hours.

Otherwise the contact impedance between the skin and electrode may increase

due to drying of the electrode gel or deterioration of adhesives and correct

measurement cannot be obtained.

If electrode contact becomes poor, replace it with a new one.

Disposing of Electrodes

Follow your local laws for disposing of medical waste. To prevent second

infection, do not dispose of the disposable pads with other waste.

SpO2 and CO2

For the SpO2 adapter, SpO2 probe, CO2 sensor cable and CO2 sensor, refer to

each operator’s manual.

Test electrode plate




10. MAINTENANCE

Check After Use

To ensure correct performance for use in an emergency, check the following

items after every usage. If you nd any trouble, check the debrillator referring

to “Troubleshooting” in Section 9 and take necessary remedial actions. If any

abnormality is found, attach a “Not available” or “Repair requested” label on the

debrillator and contact your Nihon Kohden representative.

Before turning off the power

• Temporarily changed settings on the System Setup screen and Setup screen are

returned to original settings.

• When the Energy/Mode Select control is set to DISARM position, “0 J” is


• Energy is not still being charged.

• Cables are disconnected from the debrillator.

Abnormality

• There was no abnormality during operation.

• No error indication is on the screen.

• The screen display is normal and can be seen clearly.

• The debrillator is not too hot when touched.

• All settings are as you set them.

Appearance

• The debrillator is not dirty or damaged.

• The metal plate of the paddle holder and paddle electrode is not rusted or

discolored.

• The operation panel and label on the debrillator are not dirty or missing.

• There is no crack or damage on the debrillator and paddles.

• There is no damage on the power cord.

• The battery check date and battery replacement date are not expired.

• Paddles are cleaned.

• Internal paddles are sterilized if necessary.

• There is enough contact gel (GELAID).

• If the debrillator is in contact with liquid, it is wiped and dried thoroughly.

• Accessories are kept neatly.

• Disposable pads and ECG electrodes are disposed of properly so as not to

cause second infection.

• There are enough consumables such as recording paper.

• The power cord is connected to the debrillator to maintain battery charge.

• The Energy/Mode Select control is set to OFF.

• There are no chemical solutions or water left around the debrillator.

• The debrillator storage condition is proper.



10


10. MAINTENANCE

Periodic Inspection

CAUTION

Assembly and disassembly of any component in the instrumentshould only be done by qualified service personnel.

CAUTION

Before maintenance, cleaning or disinfection, turn the defibrillator

power off, disconnect the power cord from the AC socket and

then remove the battery from the defibrillator. Failure to follow this

instruction may result in electrical shock and defibrillator malfunction.

Daily Inspection

Perform the Basic Checks every day. Refer to “Basic Checks” in Section 2.

Monthly Inspection

Check the following items once a month. If any abnormality is found, contact


• Checking external paddles

• Basic Checks• Checking 270 J energy charge and disarm

• Battery test

• HV capacitor test

• Recorder test

• Date and time adjustment

Check the battery appearance every 6 months.

To check the energy discharge, use the Basic Checks screen.

Checking External Paddles

• Check that there is no crack or damage on the resin of external paddles and

resin of adult electrodes.

• Check that there is no scratch or damage on the cables.

• Check that the plastic cover over the DISCHARGE button on the external

paddles is not removed.

• Check energy discharge. Check the operation of the CHARGE button and

DISCHARGE buttons. Conrm that there is no discontinuity in the cables.




10. MAINTENANCE

Checking 270 J Energy Charge and Disarm

Check that the debrillator automatically disarms.

1. Turn the Energy/Mode Select control to 270 J.

2. Leaving the paddles on their holders, press the CHARGE button on the

APEX paddle to start charging.

3. Conrm that there is a beeping sound, the “CHARGING” message appears

on the screen and the CHARGE lamp on the APEX paddle blinks.

4. When charging is completed, there is a continuous buzzing sound and the

CHARGE lamp lights. Conrm that the “CHARGED” message and “270 J”

is displayed on the screen.

5. Turn the Energy/Mode select control to the DISARM position.

6. Check that the energy value on the lower right of the screen changes to 0 J in

20 seconds. If not, contact your Nihon Kohden representative.

NOTE

• Do not discharge manually by pressing the DISCHARGE buttons.

• If any error message appears during the test, contact your Nihon


• Do not continuously perform this check more than the specified number

of charge/discharge cycles. Refer to “Specification - Defibrillator -

Maximum continuous charge/discharge cycles at 270 J” in Section 11.



10


10. MAINTENANCE

Battery Test

This checks the battery capacity by charging and discharging the battery. Perform

this test once a month.

WARNING

• Test the battery pack once a month.• When you start using a new battery pack, write the date of first use

on the labels on the battery pack and defibrillator.

• Replace the battery pack every two years.

• If defibrillation or cardioversion is necessary during the battery

test, cancel the battery test and operate the defibrillator on AC

power. Do not use battery power because the battery pack may

have been discharged by the battery test.

NOTE

• It takes about 4.5 hours to test a fully charged new battery at the 20°C

ambient temperature. It takes up to 6 hours to test a battery which has

little remaining charge.

• If the power cord is disconnected from the defibrillator during the

battery test, the battery test is canceled. Before starting the battery

test, firmly connect the power cord to the AC outlet on the wall and the

defibrillator.

• If there is a difference in temperature between the battery and the

defibrillator, the battery test cannot be done properly. In such a case

(for example, when you test the extra battery), insert the battery in the

defibrillator and leave it for 3 hours, then perform the battery test.

1. On the System Setup - Menu screen, select “Battery Test” with the Item key

and press the OK key. The System Setup - Battery Test screen appears.

2. Conrm that the battery is properly installed.

3. Connect the power cord to the AC outlet.

4. Conrm that enough recording paper is loaded in the recording unit. If not,

load it.

5. Press the START key to start the battery test.

• When the battery is not fully charged, it is charged, then discharged.

• When the battery is fully charged, it is immediately discharged.

A message shows the progress of the test.

Checking battery: Battery is being charged for the battery test.

Battery is being discharged.

Battery is being charged for the next use.

Test result XX %: Test nished.




10. MAINTENANCE

NOTE

When the battery temperature is high, an error message and the

battery test result appear on the screen, and the battery charging

stops. With the power cord connected, turn the Energy/Mode Select

control to OFF to reduce the battery temperature, and make sure

to continue the battery charging for the next use. (Refer to “Error

Messages During Battery Test” table.)

To stop the battery test, press the STOP key.

6. When test nishes, the result appears on the screen.

Press the Reset key only when the battery pack is replaced.

Refer to “Inserting the Battery into the Debrillator” in Section 2.

Test Result Description Action

Battery OK XXX%

(Capacity XXX%: 100%, 80% 70%)

Capacity is enough. Battery operation is available anytime.

When the debrillator is not used, always

do trickle charging.

Battery WEAK XXX%

(Capacity XXX%: 60%, 50%)

Capacity has decreased under

70%.

Battery operation is available only when

the battery is fully charged. The time to

replace the battery is coming soon. It is

recommended to replace the battery with a

new one.

Replace battery XXX%

(Capacity XXX%: 40%, 0%)

Capacity has decreased under

50%.

Only AC operation is available.

Immediately replace the battery with anew one. Contact your Nihon Kohden

representative.

Battery capacity is shown as 100, 80, 70, 60, 50, 40 and 0%.

While the test result is displayed on the screen, you can print the test result

by pressing the Record key.

NOTE

• Even when the capacity is 100 to 70%, replace a battery which has

been used for more than two years.

• When you cannot confirm the capacity (%) after battery test is

done, press the Record key to confirm that the battery test is

correctly done.



10


10. MAINTENANCE

• Do not press the Menu key during battery test. Otherwise the

screen may switch to the setup screen.

Error Messages During Battery Test


Insert battery Battery test cannot be done because the

battery is not inserted in the debrillator.

First disconnect the power cord and then

insert the battery into the debrillator. Do

the test again.

Connect to AC power Battery test cannot be done because AC

power is not supplied to the debrillator.

Supply AC power to the debrillator and

do the test again.

Battery discharge timed out A battery other than the specied one is used.

Or debrillator abnormality.

Use the specied battery pack. If it does

not solve the problem and the message

still appears, contact your Nihon Kohden

representative.Battery charge timed out A battery other than the specied one is used.

Or the battery is deteriorated.

Battery charging error Faulty debrillator Contact your Nihon Kohden

representative.

Battery FET Error Faulty debrillator Contact your Nihon Kohden

representative.Battery charging stopped due

to increased temperature.

Turn Energy/Mode Select to

OFF to charge battery

The battery temperature is high and the

battery charging stops.

With the power cord connected, turn the

Energy/Mode Select control to OFF, and

continue the battery charging for the next

use.


Checking the Battery Appearance

To prevent battery trouble, check the battery appearance every 6 months. The

check schedule should be written on the battery check label attached to the

debrillator.

1. Check the outside appearance of the battery pack. If there is any damage

(crack, deformation, cable discontinuity and so on) on the battery or the

battery leaks, replace the battery with a new one. If the battery is dirty with

dust, remove it.

If the battery check label says it is the day to replace the battery, replace the

battery with a new one.

2. After checking, change the battery check label. If the battery is replaced,

write down the date of the rst use on the new battery.




10. MAINTENANCE

HV Capacitor Test

This checks the performance of the HV (high voltage) capacitor to charge the

debrillation energy. During this check, the capacitor is charged and disarms.

NOTE

Make sure that the AC power cord is connected to ensure the battery

charge for emergency operation.

1. On the System Setup - Menu screen, select “HV Capacitor Test” with the

Item key and press the OK key. The System Setup - HV Capacitor Test

screen appears.

2. Set the Energy/Mode Select control to 200 J.

NOTE

If the energy is not set to 200 J, HV capacitor test cannot be done.

3. Press the CHARGE button on the external paddle (APEX) or the CHARGE/

AED button on the front panel to charge energy. The debrillator charges the

selected energy. After charging is completed, the debrillator automatically

disarms and measures the discharge energy. The check result appears on the

screen.

NOTE

During charging, if the Energy/Mode Select control is turned to

another position, the defibrillator immediately disarms.

Test Result Description

Capacitance XXX%

Capacitor test pass

100-80%:

Capacitor performance is OK. It can be used at any

time.

Capacitance XXX%

Capacitor test fail

0-79%:

Capacitor life is almost over. Replace it with a new

one. Contact your Nihon Kohden representative.

4. Press the key for “Menu” to return to the System Setup - Menu screen.




10. MAINTENANCE

Periodical Replacement Schedule

To maintain the performance of the debrillator, the following parts must be

periodically replaced.

Battery pack, YZ-024H9: Every 2 years

Pad adapter, JC-765V (option for P-511 and P-513 pads): Every 2 years

Pad adapter, JC-755V (option for R2 pads): Every 2 years

Test electrode plate, T0.2, 6114-124377 Every 2 years

Repair Parts Availability Policy

Nihon Kohden Corporation (NKC) shall stock repair parts (parts necessary to

maintain the performance of the instrument) for a period of 8 years from the

date of delivery. In that period NKC or its authorized agents will repair the

instrument. This period may be shorter than 8 years if the board or part necessary

for the faulty section is not available.

Storage

NOTE

The operating environment must be more than 0°C. (Refer to

“Specifications” in Section 11.) Otherwise the high voltage capacitor may

get damaged. If the defibrillator was stored below −5°C (23°F), leave it for

3 hours or more in at least 0°C (32°F) before using it.

Defibrillator and Battery

Before storage, clean the debrillator, cables and paddles as described in

“Cleaning, Disinfecting and Sterilization” in this section. When disposable

pads or internal paddles are connected to the debrillator, disconnect them and

connect external paddles to the debrillator.

Short Term Storage (Ready for Use at Any Time)

CAUTIONTo prevent overheating, leave the defibrillator lying flat and do not

cover it.



10


10. MAINTENANCE

• When the debrillator is not used, always connect it to AC power to maintain

the battery charge with trickle charging. Conrm that the AC lamp is on.

• Check the battery appearance every 6 months and do the battery test every

month.

• Store in a cool place (–20 to +35°C, –4 to +95°F). If the debrillator is stored

in high temperature, the battery deteriorates.

Long Term Storage

• If you store the debrillator not connected to AC power, remove the battery

from the debrillator. Otherwise, the battery over-discharged after 1 month in

the debrillator without AC power.

• When you store a battery outside the debrillator, do the battery test every 6

months.

• Store the battery and debrillator in a cool place (–20 to +35°C, –4 to +95°F).

If the battery is stored at high temperature, it deteriorates.

Disposable Pads and ECG Electrodes

CAUTION

Store the disposable pads in the environment described on the pads

package. If stored in an environment other than specified, the pads

become unusable.

CAUTION

Do not put heavy objects on the disposable pads or bend the pads.The pads may be damaged and deteriorated, resulting in skin burn

on the patient.

• Store the disposable pads and ECG electrodes in a cool place (5 to 35°C, 41 to

95°F).

• Each pad has its own lifetime. Use the pad within its lifetime.

• Do not put heavy thing on pads and ECG electrodes. Otherwise, the gel may

ow out.




11

Section 11 Reference

Specifications ....................................................................................................................................................11.2

Defibrillator ..............................................................................................................................................11.2

Noninvasive Pacing (TEC-5531 Only) ..................................................................................................... 11.4

External Paddle (ND-552VB/VE/VK) ....................................................................................................... 11.4

Battery .....................................................................................................................................................11.4

Clock Accuracy ........................................................................................................................................ 11.4

Environment ............................................................................................................................................11.4

Safety ......................................................................................................................................................11.4

Monitor ....................................................................................................................................................11.5

ECG Amplifier..........................................................................................................................................11.5Recorder .................................................................................................................................................. 11.5

Rhythm Recognition Detector .................................................................................................................11.5

Power Requirements ...............................................................................................................................11.6

Dimensions and Weight ........................................................................................................................... 11.6

Electromagnetic Compatibility .................................................................................................................11.6

Electromagnetic Emissions .....................................................................................................................11.7

Electromagnetic Immunity .......................................................................................................................11.7

Recommended Separation Distances between Portable and Mobile RF Communications

Equipment ............................................................................................................................................. 11.10

Reference ........................................................................................................................................................ 11.11Standard Accessories ..................................................................................................................................... 11.12

Options/Consumables ..................................................................................................................................... 11.12

Pin Assignment ................................................................................................................................................ 11.15

AUX Connector of the QI-553V DSI/AUX OUT Interface Unit ............................................................... 11.15

General Requirements for Connecting Medical Electrical Systems ................................................................ 11.16




11. REFERENCE

Specifications

Defibrillator

Output energy (across 50 Ω): 2, 3, 5, 7, 10, 15, 20, 30, 50, 70, 100, 150, 200 and 270 J

Energy accuracy: 2 J: ±0.5 J, 3 J: ±1 J, 5 to 15 J: ±2 J, 20 to 270 J: ±10%

Output waveform: Biphasic, truncated exponential constant power (across 50 Ω)

Charging time:

Manual mode:

When powered by AC 100 V to 240 V: to 270 J, maximum 5 s

to 200 J, maximum 3 s

When powered by 90% of the rated mains voltage: to 270 J, maximum 5 s

When powered by a fully charged new battery at 20°C ambient temperature:



After 15 discharges at 270 J with a fully charged new battery at 20°C ambient temperature:


When powered by 90% of the rated mains voltage or after 15 discharges at 270 J with a fully charged new

battery at 20°C ambient temperature: Power on to 270 J, maximum 7 s

AED mode:

When powered by 90% of the rated mains voltage or after 15 discharges at 270 J with a fully charged new

battery at 20°C ambient temperature: Power on to 270 J: 14 to 23 s

Standby mode to 270 J: 12 to 21 s

Charging display: Displays the charged energy value on the screen

Synchronized discharge: Available

From the peak of R wave to the peak of discharge: within 60 msMaximum continuous charge/discharge cycles at 270 J:

20 cycles: 3 cycles per minute with 1 minute cool down period after every 1 minute charge/

discharge period

15 cycles: 3 cycles per minute with no cool down period

Maximum skin-disposable pad contact impedance for energy charging: 350 Ω

Discharge waveform

Ipk1

D1It

Ipk2D2



11


11. REFERENCE

Delivered energy: 270 J

Load Resistance(Ω)

First Phase Second Phase

Peak CurrentIpk1 (A)

Pulse WidthD1 (ms)

TerminalCurrent

It (A)


Pulse WidthD2 (ms)

25 67.3 3.85 26.80 15.5 3.62

50 41.1 6.35 15.50 12.7 3.6275 29.5 8.86 11.00 11.0 3.62

100 22.9 11.4 8.50 9.81 3.62

125 18.8 13.9 6.94 8.96 3.62

150 15.9 16.4 5.86 8.29 3.62

175 13.8 18.9 5.08 7.76 3.62

Delivered energy: 150 J

Load Resistance(Ω)

First Phase Second Phase


Pulse WidthD1 (ms)

TerminalCurrent

It (A)


Pulse Width(50%)

D275 22.1 ±10% 8.86 ±10% 8.19 ±10% 8.19 ±20% 3.62 ±10%

Output Waveforms (200 J): 25, 50, 75, 100, 125, 150, 175 Ω




11. REFERENCE

Noninvasive Pacing (TEC-5531 Only)

Pacing rate: 30 to 180 pulse/min ±10% in 10 pulse/min steps

Output current: 8 to 200 mA (accuracy of ± 2 mA or ±10%, whichever greater, at 250 Ω) in 1, 2,

5 or 10 mA steps (Set on the System Setup screen.)

Pacing modes: Fixed and Demand

Maximum load resistance: Outputs 200 mA across 250 Ω, 120 mA across 500 Ω

Pulse width: 40 ms±10%

Pacing pulse waveform: Modified trapezoidal

External Paddle (ND-552VB/VE/VK)

Paddle electrode size: For adults: 70 ±3 × 106 ±3 (mm2)

For children: 45 ±3 × 53 ±3 (mm2)

Paddle cord length: 2.0 m or more (When it is pulled by 18 N force.)

Battery

Type: Ni-MH battery: Nominal voltage: 12 V

Rated capacity: 2800 mAh

Capacity: With fully charged new battery at 20°C (68°F) ambient temperature

• Minimum 70 discharges at 270 J

• Minimum 150 minutes continuous monitoring

• Minimum 90 minutes xed mode pacing (180 pulse/min, 200 mA)

With the fully charged new battery at 0°C (32°F)

• Minimum 50 discharges at 270 J

Clock Accuracy

At surrounding temperature 25°C (77°F): ±3 min/month

At storage temperatures –20 to +70°C (–4 to +158°F): ±5 min/month

Environment

Operating temperature: 0 to 45°C (32 to 113°F)

Operating humidity: 30 to 95% (relative humidity, noncondensing)

(Recording paper may jam, if it is wet.)

Operating atmospheric pressure: 700 to 1060 hPa

Storage temperature: −20 to +70°C (−4 to +158°F)

Storage humidity: 10 to 95% (relative humidity)

Storage atmospheric pressure: 500 to 1060 hPa

Safety

Safety standard: IEC 60601-1: 1988

IEC 60601-1 Amendment 1: 1991

IEC 60601-1 Amendment 2: 1995

IEC 60601-1-2: 2001

IEC 60601-1-2: Amendment 1: 2004

IEC 60601-2-4: 2002

Type of protection against electrical shock:

Battery power: INTERNALLY POWERED EQUIPMENT

AC power: CLASS I EQUIPMENT



11


11. REFERENCE

Degree of protection against electrical shock:

DEFIBRILLATION-PROOF TYPE BF APPLIED PART:

External paddles, disposable pads, SpO2 adapter and CO2 sensor kit

DEFIBRILLATION-PROOF TYPE CF APPLIED PART:

Internal paddles, ECG connection cable

Degree of protection against harmful ingress of water:

IPX1 (Protected against vertically falling water drops)

Degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH

OXYGEN OR NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of FLAMMABLE

ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS

OXIDE

Mode of operation:

Continuous operation with intermittent load: Operation at debrillation mode

Continuous operation: All operation except above mentioned

Monitor

Effective display area: 115.2 (W) × 86.4 (H) mm (5.7 inch)

Sweep length: 97 mm

Sweep speed: 25 mm/s, 50 mm/s

Sensitivity: 10 mm/1 mV ±5% (sensitivity ×1)

Amplitude limit: 40 mm

ECG Amplifier

Input signal: PADDLE, I, II, III, aVR, aVL, aVF, V, AUX

Frequency response: Through paddles: 0.5 to 20 Hz (–3 dB)

Through ECG connection cable: 0.05 to 150 Hz (–3 dB)

AUX: 0.05 to 150 Hz (–3 dB)

Input impedance: Through paddles: ≥ 100 kΩ

Through ECG connection cable: ≥ 5 MΩ (at 10 Hz 1 mV)

AUX: ≥ 100 kΩ ±10%

CMRR: ≥ 100 dB (against chassis ground) when AC lter is ON

AC lter: Available (common with 50/60 Hz)

ON at ≥ –20 dB, OFF

Pacing pulse rejection: ON, OFF

External ECG input sensitivity: 10 mm/V ±5% (sensitivity ×1)

Heart rate counting range: Debrillation or monitoring mode: 15 to 300 bpm

Pacing mode: 15 to 220 bpm

Recorder

Paper speed: Real time/delayed ECG waveform recording: 50, 25 mm/s

Types of recording:

Manual recording: Real time/delayed waveform recording, report recording, event recording

Automatic recording: Record on charging after discharge, alarm recording, periodic recording

Rhythm Recognition Detector

We evaluated the rhythm recognition detector of the TEC-5500 series debrillator using the ofcial electrocardiogram

database provided by AHA (American Heart Association) and MIT (Massachusetts Institute of Technology) and an

electrocardiogram database of over 3000 electrocardiograms from hospitals in Japan. According to our own evaluation, the

rhythm recognition detector of the TEC-5500 series debrillator meets the equivalent of AAMI standards ANSI/AAMI DF-

39-1993 3.3.18.




11. REFERENCE

Shockable Rhythm VF: Sensitivity: ≥ 90%

Shockable Rhythm VT: Sensitivity: ≥ 75%

All other Non-Shockable Rhythm: Sensitivity: ≥ 95%

Power Requirements

AC: Line voltage: 100 to 240 V

Line frequency: 50/60 Hz (automatic switching)

Power input: Intermittent load: 450 VA or less

Continuous load: 200 VA or less

DC (Battery): Power voltage: 12 V

Power consumption: Intermittent load: 18 A or less

Continuous load: 4.2 A or less

Charging time: 3 hours or less (with AC, with the power OFF)

Dimensions and Weight

Dimensions: 290 (W) × 172 (H) × 355 (D) mm

Weight: TEC-5521 debrillator: 6.1 kg (External paddles use, AC unit without battery)

5.3 kg (Pad adapter use, AC unit without battery)

TEC-5531 debrillator: 6.3 kg (External paddles use, AC unit without battery)

5.5 kg (Pad adapter use, AC unit without battery)

Electromagnetic Compatibility

Standard

IEC 60601-1-2: 2001

Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic

compatibility - Requirements and tests

IEC 60601-1-2 Amendment 1: 2004

IEC 60601-2-4: 2002

Medical electrical equipment - Part 2-4: Particular requirement for the safety of cardiac debrillators



11


11. REFERENCE

Electromagnetic Emissions

The TEC-5500’s essential performances in EMC standard satisfy the following criteria.

The TEC-5500 series is intended for use in the electromagnetic environment specied below. The customer or the user of

the TEC-5500 series should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissionsCISPR 11

Group 1

The TEC-5500 series uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause

any interference in nearby electronic equipment.

RF emissions

CISPR 11Class B

The TEC-5500 series is suitable for use in all establishments, including

domestic establishments and those directly connected to the public

low-voltage power supply network that supplies buildings used for

domestic purposes.Harmonic emissions

IEC 61000-3-2Class A

Voltage uctuations/

icker emissions

IEC 61000-3-3

Complies

Electromagnetic Immunity

The TEC-5500’s essential performances in EMC standard satisfy the following criteria.

The TEC-5500 series is intended for use in the electromagnetic environment specied below. The customer or the user of

the TEC-5500 series should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance levelElectromagnetic environment –

guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic

tile. If oors are covered with synthetic

material, the relative humidity should be at

least 30%.

Electrical fast

transient/burstIEC 61000-4-4

±2 kV for power supply

lines

±2 kV for power supply

lines

Mains power quality should be that

of a typical commercial or hospitalenvironment.

Surge

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential mode

±2 kV common mode


of a typical commercial or hospital

environment.

Voltage dips, short

interruptions and

voltage variations on

power supply input lines

IEC 61000-4-11

< 5% Ut

(> 95 % dip in Ut ) for

0.5 cycles

40% Ut

(60% dip in Ut ) for

5 cycles

70% Ut


25 cycles

< 5% Ut

(> 95% dip in Ut ) for

0.5 cycles

40% Ut

(60 % dip in Ut ) for

5 cycles

70% Ut


25 cycles



environment. If the user of the TEC-

5500 series requires continued operation

during power mains interruptions, it is

recommended that the TEC-5500 series

be powered from an uninterruptible power

supply or a battery.

Voltage dips, short

interruptions and

voltage variations on

power supply input lines

IEC 61000-4-11

< 5% Ut


5 seconds

< 5% Ut


5 seconds



environment. If the user of the TEC-

5500 series requires continued operation

during power mains interruptions, it is

recommended that the TEC-5500 series

be powered from an uninterruptible power

supply or a battery.

Power frequency(50/60 Hz) magnetic

eld

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic elds should be at levels characteristic of a typical

location in a typical commercial or hospital

environment.

NOTE: Ut is the AC mains voltage prior to application of the test level.



11


11. REFERENCE

Immunity test IEC 60601test levelCompliance

levelElectromagnetic environment – guidance

Radiated RF

IEC 61000-4-3

Requirement of

IEC-60601-2-4:

Correct operation of RRD:

10 V/m

80 MHz to 2.5 GHz

No inadvertent energy delivery isallowed:

20 V/m

80 MHz to 2.5 GHz

3 V/m

20 V/m

Portable and mobile RF communications

equipment should be used no closer to any part of

the TEC-5500 series, including cables, than the

recommended separation distance calculated from

the equation applicable to the frequency of the

transmitter.

Recommended separation distance

d = 1.2 P 80 to 800 MHz

d = 2.3 P 800 MHz to 2.5 GHz

Additional requirement of IEC 60601-2-4

Correct operation of RRD:

d = 4.0 P 80 to 800 MHz

d = 7.7 P 800 MHz to 2.5 GHz

No inadvertent energy delivery is allowed:

d = 0.6 P 80 to 800 MHz

d = 1.2 P 800 MHz to 2.5 GHz

where P is the maximum output power rating

of the transmitter in watts (W) according to the

transmitter manufacturer and d is the recommended

separation distance in meters (m).*2

Field strengths from xed RF transmitters, as deter

mined by an electromagnetic site survey,*3 should

be less than the compliance level in each frequencyrange.*4

Interference may occur in the vicinity of equipment

marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and

reection from structures, objects and people.

*1 The ISM (industrial, scientic and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;

13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

*2 The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80

MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could causeinterference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in

calculating the recommended separation distance for transmitters in these frequency ranges.

*3 Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile

radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.

To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be

considered. If the measured eld strength in the location in which the TEC-5500 series is used exceeds the applicable

RF compliance level above, the TEC-5500 series should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as re-orienting or relocating the TEC-5500

series.

*4 Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.




11. REFERENCE

Recommended Separation Distances between Portable and Mobile RF Communications Equipment

The TEC-5500 series is intended for use in an electromagnetic environment in which radiated RF disturbances are

controlled. The customer or the user of the TEC-5500 series can help prevent electromagnetic interference by maintaining a

minimum distance between portable and mobile RF communications equipment (transmitters) and the TEC-5500 series as

recommended below, according to the maximum output power of the communications equipment.

Rated maximum outputpower of transmitter (W)

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHzoutside ISM bands

d = 1.2 P

150 kHz to 80 MHzin ISM bands

d = 1.2 P

80 MHz to 800 MHzd = 4.0 P

800 MHz to 2.5 GHzd = 7.7 P

0.01 0.12 0.12 0.4 0.77

0.1 0.38 0.38 1.3 2.4

1 1.2 1.2 4.0 7.7

10 3.8 3.8 13 27

100 12 12 40 77

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters

(m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output

power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: The ISM (industrial, scientic and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to

6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

NOTE 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in

the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz

to decrease the likelihood that mobile/portable communications equipment could cause interference if it is

inadvertently brought into patient areas.

NOTE 4: These guidelines might not apply in all situations. Electromagnetic propagation is affected by absorption and

reection from structures, objects and people.

The equations and values in the above table show the condition that the RRD (Rhythm Recognition Detector) regulated

in IEC 60601-2-4: 2002 does not receive electromagnetic interference.

System Conguration for EMC Test

We tested that the debrillator complies with IEC 60601-1-1: 2001, Amendment 1: 2004 and IEC 60601-2-4: 2002 with

the following conguration. If other cables and equipments are used with the debrillator, the debrillator may not comply

with these standards.

Configuration at testing Cable length (m)

Debrillator, TEC-5521/5531 series —

DSI interface unit, QI-552V —

External paddles, ND-552V 0.406

Pad adapter, JC-765V* 3.50

ECG connection cable, BC-763V 3.30

CO2 sensor kit, TG-901T3 2.99

SpO2 adapter, JL-951T3** 2.50

Finger probe, TL-201T** 1.60

Battery pack, NKB-301V (YZ-024H9) —

Holter card, QM-064D —

* When the pad adapter is connected to the

debrillator, the compliance level of the item

“Radiated RF” (IEC 60601-2-4: 2002) is 3 V/m.

** When the SpO2 adapter and nger probe are

connected to the debrillator, the debrillator does

not comply with the item “Conducted RF” (IEC

60601-1-2: 2001).



11


11. REFERENCE

Reference

1. KERBER, RE, CARTER, J., KLEIN, S, et al.

Open chest debrillation during cardiac surgery: Energy and current

requirements.

American Journal of Cardiology, 46:393-396, 1980

2. RACKER, WA, GUINN, GA, GEDDES, LA, et al.

The electrical dose for direct ventricular debrillation in man.

Journal of Thoracic Cardiovascular Surgery, 75:224-226, 1978

3. RUBIO, PA and FARRELL, EM.

Low-energy direct debrillation of the human heart

Annals of Thoracic Surgery, 27:32-33, 1979




11. REFERENCE

Standard Accessories

No. Name Qty Model/Code No. Supply Code

1 Recording paper (Z-fold) 1 FQS50-2-100 A226

2 Contact gel GELAID 1 — F015

3Battery check label

(for debrillator)1 6124-022441 —

NOTE

When you order accessories/consumables which have a supply code,

specify the supply code, not the model or code number.

Options/Consumables

Name Qty Model Supply Code

TEC accessory set (100V/IEC)

BC-763V ECG connection cable (IEC, 3 leads) +

Power cord H

1 YZ-024H3 —

TEC accessory set (200V/IEC)

BC-763V ECG connection cable (IEC, 3 leads) +

Power cord N

1 YZ-024H4 —

TEC accessory set (100V/AHA)

BC-763VA ECG connection cable (AHA, 3 leads) +Power cord H

1 YZ-024H5 —

TEC accessory set (200/AHA)

BC-763VA ECG connection cable (AHA, 3 leads) +

Power cord N

1 YZ-024H6 —

ECG connection cable (IEC, 3 leads) 1 BC-763V K353A

ECG connection cable (AHA, 3 leads) 1 BC-763VA K352A

ECG connection cable (IEC, 5 leads) 1 BC-765V K353B

ECG connection cable (AHA, 5 leads) 1 BC-765VA K352B

External ECG cable 1 JC-761V L151

Connection cable 1 JC-762V L152

Connection cable 1 JC-763V L153

Pad adapter for P-511/P-513 1 JC-765V —

Pad adapter for R2 pads 1 JC-755V —

Battery pack NKB-301V 1 YZ-024H9 X065

Power cord type N 1 — L936

Power cord type H 1 — L935

Cart 1 KD-028A —

Cart tray assembly (option for the cart) 1 DI-001A —

Paste holder kit 1 set YZ-025H0 —

Disposable ECG electrode Vitrode C 150/set — G204

Disposable pad for adult 1 set P-511 H327

Disposable pad for infant 1 set P-513 H312

Internal paddles (with switch, 35 mm Ø) 1 ND-593V —






11. REFERENCE

Name Qty Model Supply Code

CO2 measurement

CO2 sensor kit 1 TG-901T3 P906

Airway adapter for TG-901T3 CO2 sensor kit 50/set YG-101T R801

CO2 sensor kit 1 TG-921T3 P908

Nasal Adapter (for nasal breathing) for TG-921T3 CO2

sensor kit

30/set YG-120T V921

Nasal Adapter (for naso-oral breathing) for TG-921T3

CO2 sensor kit

30/set YG-121T V922

Nasal Adapter (for oxygen cannula adjustment) for

TG-921T3 CO2 sensor kit

30/set YG-122T V923

Airway adapter for TG-921T3 CO2 sensor kit 30/set YG-111T R804

SpO2 measurement

SpO2 adapter 1 JL-550T2 Y095

Finger probe BluPRO 1 TL-201T P225F

Multi-site probe BluPRO 1 TL-220T P225G

Multi-site Y prove 1 TL-260T P205A

SpO2 probe (for adult) (0.8 m) BluPRO 5/pcs TL-271T P203ASpO2 probe (for child) (0.8 m) BluPRO 5/pcs TL-272T P204B

SpO2 probe (for neonate) (0.8m) BluPRO 5/pcs TL-273T P204C

SpO2 probe (for infant) (0.8m) BluPRO 5/pcs TL-274T P204D

SpO2 probe (for adult and neonate) (0.8 m) 5/pcs TL-051S P228A

SpO2 probe (for adult and neonate) (1.6 m) 5/pcs TL-052S P228B

SpO2 probe (for adult, child and infant) (0.8 m) 5/pcs TL-061S P229A

SpO2 probe (for adult, child and infant) (1.6 m) 5/pcs TL-062S P229B

Cottony tape 20 — P259

There are two types of TG-921T3 CO2 sensor kit. One complies with IEC 60601-

1-2: 2001, the other does not. CO2 sensor kits which comply with this standardhave a IEC 60601-1-2: 2001 stamp. The debrillator only complies with this

standard used with the CO2 sensor kit which complies with this standard.



11


11. REFERENCE

Pin Assignment

WARNING

Connect only the specified instrument to the defibrillator and followthe specified procedure. Failure to follow this warning may result in

electrical shock or injury to the patient and operator, and cause fire

or instrument malfunction.

AUX Connector of the QI-553V DSI/AUX OUT Interface Unit

This connector is for analog ECG output.

Mating plug: 3.5 mm diameter plug

Output sensitivity: 0.5 V/1 mV ±10%

Output impedance: 1 kΩ or less




11. REFERENCE

General Requirements for Connecting Medical Electrical

Systems

When more than one electrical instrument is used, there may be electrical

potential difference between the instruments. Potential difference between

instruments may cause current to ow to the patient connected to the

instruments, resulting in electrical shock. Therefore, electrical instruments must

be appropriately installed as specied in IEC 60601-1-1: 2000 Second edition.

The following is an extract from IEC 60601-1-1 “Medical electrical equipment

Part 1-1: General requirements for safety”. For details, refer to IEC 60601-1-1

and consult with a biomedical engineer.

Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and non-medical electrical equipment

Inside the PATIENT

ENVIRONMENT

Outside the

PATIENT

ENVIRONMENT

1a Items A and B in

PATIENT

ENVIRONMENT

1b Items A and B in

PATIENT

ENVIRONMENT

For B: Additional

protective earth or

separating transformer

1c Item A powered

from specified power

supply in item B in

PATIENT

ENVIRONMENT

For B: Additional

protective earth or

separating transformer

2a Item A in

PATIENT

ENVIRONMENT and

item B in medically

used room

2b Item A in

PATIENT

ENVIRONMENT anditem B in medically

used room

For B: See 19.201 and its

rationale

3a Item A in

PATIENT

ENVIRONMENT and

item B in non-medically

used room

For B: See 19.201 and its

rationale

3b Item A in

PATIENT

ENVIRONMENT and

item B in non-medicallyused room

For B: Additional

protective earth or

SEPARATION DEVICE

Medically used roomNon-medically used

room

Feasible solution (See

clause 19 in all

situations)

1

2

3

Situation No.

A

IEC

60601

B

IEC

60601

A

IEC

60601

B

IEC

XXXXX

A

IEC

60601

B

IEC

60601

A

IEC

60601

B

IEC

XXXXX

A

IEC

60601

B

IEC 60601

or

IEC XXXXX

A

IEC

60601

protective earth with

potential differenceprotective earth

A

IEC 60601

B

IEC XXXXX

common protective earth

B

IEC 60601

or

IEC XXXXX



Manufacturer

NIHON KOHDEN CORPORATION NIHON KOHDEN ITALIA S.r.l.

defibri lad or

Documents